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Various Medical Devices Recalled by Biomet 3i (2015-11-30), Part 2
- Starting date:
- November 30, 2015
- Posting date:
- January 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56660
Affected Products
- Bh. DAL-RO HOUSING THREADED FEMALE
- Bi. DAL-RO HOUSING/FEMALE ASSEMBLY
- Bj. LOCATOR REPLACEMENT HOUSING
- Bk. CERTAIN MICROMINIPLANT PERFORMANCE POST
- Bl. CERTAIN MICROMINIPLANT PREFORMANE PRE-ANGLED POST
- Bm. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CYLINDER
- Bn. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
- Bo. LOCATOR EXTRA LIGHT ANGLE REPLACEMENT MALE
- Bp. PREFORMANCE POST
- Bq. PREFORMANCE PRE-ANGLED POST
- Br. MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
- Bs. PREFORMANCE TEMPORARY CYLINDER
- Bt. MICROMINIPLANT LOCATOR ABUTMENT
- Bu. CERTAIN MICROMINIPLANT LOCATOR ABUTMENT
- Bv. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
- Bw. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
- Bx. WIDE DIAMETER 5.0MM EP ONE-PIECE HEALING ABUTMENT
- By. LOCATOR ABUTMENT
- Bz. LOCATOR ABUTMENT IMPRESSION COPING
- Ca. LOCATOR REPLACEMENT MALES
- Cb. GINGIHUE 15 DEGREE PRE-ANGLED POST
- Cc. STA ABUTMENTS - STANDARD ABUTMENT
- Cd. STA ABUTMENTS-MICROMINIPLANT GINGIHUE POST
- Ce. STA ABUTMENTS-CONICAL ABUTMENT GOLD STANDARD
- Cf. STA ABUTMENTS-CONICAL ABUTMENT
- Cg. STA ABUTMENTS-GINGIHUE POST W/SLA
- Ch. GINGIHUE PRE-ANGLED POST
- Ci. STA ABUTMENTS-STANDARD ABUTMENT
- Cj. STA ABUTMENTS-CERTAIN CONICAL ABUTMENT
- Ck. CERTAIN LOCATOR ABUTMENTS
- Cl. CERTAIN HEALING ABUTMENT
- Cm. WIDE DIAMETER ONE-PIECE CERTAIN HEALING ABUTMENT
- Cn. ONE-PIECE CERTAIN MICROMINIPLANT HEALING ABUTMENT
- Co. CERTAIN GOLD-TITE HEXED LARGE DIAMETER SCREW
- Cp. GOLD-TITE SQUARE UNISCREW
- Cq. GOLD-TITE HEXED RETAINING SCREW
- Cr. LOCATOR LIGHT RETENTION MALES
- Cs. LOCATOR EXTENDED RANGE MALES
- Ct. CERTAIN GINGIHUE POST (ABUTMENT)
- Cu. CERTAIN EP HEALING ABUTMENT
Reason
During the investigation of a customer complaint, two packages of LOCATOR Abutments (LOA002) were confirmed to have not been sealed during manufacturing.
Affected products
Bh. DAL-RO HOUSING THREADED FEMALE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DRAF
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bi. DAL-RO HOUSING/FEMALE ASSEMBLY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DRTH
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bj. LOCATOR REPLACEMENT HOUSING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LOAH LORHK
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bk. CERTAIN MICROMINIPLANT PERFORMANCE POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMPFP34
IMPFP354
IMPFP356
IMPFP36
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bl. CERTAIN MICROMINIPLANT PREFORMANE PRE-ANGLED POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMPAPF354
IMPAPF356
IMPAPF36
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bm. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMPFTC32
IMPFTC34
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bn. CERTAIN MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IPFP456
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bo. LOCATOR EXTRA LIGHT ANGLE REPLACEMENT MALE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LAELM LELARM
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bp. PREFORMANCE POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PFP454
PFP456
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bq. PREFORMANCE PRE-ANGLED POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PAPF454
PAPF456
PAPF554
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Br. MICROMINIPLANT PREFORMANCE TEMPORARY CLYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MPFTC32
MPFTC34
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bs. PREFORMANCE TEMPORARY CYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bt. MICROMINIPLANT LOCATOR ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MLOA001
MLOA002
MLOA003
MLOA004
MLOA005
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bu. CERTAIN MICROMINIPLANT LOCATOR ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMLOA001
IMLOA002
IMLOA003
IMLOA004
IMLOA005
IMLOA006
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bv. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
AC4217
AC4225
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bw. STA ABUTMENTS - CONICAL ANGLED ABUTMENTS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IAC4217
IAC4225
IAC4417
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bx. WIDE DIAMETER 5.0MM EP ONE-PIECE HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
By. LOCATOR ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LOA001
LOA002
LOA003
LOA004
LOA005
LOA006
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bz. LOCATOR ABUTMENT IMPRESSION COPING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LAIC1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ca. LOCATOR REPLACEMENT MALES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LARMS
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cb. GINGIHUE 15 DEGREE PRE-ANGLED POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
PAP454G
PAP462G
PAP552G
PAP554G
PAP562G
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cc. STA ABUTMENTS - STANDARD ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
AB200
AB300
AB400
AB550
AB700
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cc. STA ABUTMENTS-MICROMINIPLANT GINGIHUE POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MPAP32G
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cd. STA ABUTMENTS-CONICAL ABUTMENT GOLD STANDARD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SCA004
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cf. STA ABUTMENTS-CONICAL ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CA002
CA004
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cg. STA ABUTMENTS-GINGIHUE POST W/SLA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GSH20
GSH30
GSH7
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ch. GINGIHUE PRE-ANGLED POST
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ci. STA ABUTMENTS-STANDARD ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IAB200
IAB300
IAB400
IAB550
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cj. STA ABUTMENTS-CERTAIN CONICAL ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ICA001 ICA002 ICA003 ICA004
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ck. CERTAIN LOCATOR ABUTMENTS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ILOA001
ILOA002
ILOA003
ILOA004
ILOA005
ILOA006
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cl. CERTAIN HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cm. WIDE DIAMETER ONE-PIECE CERTAIN HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
More than 10 numbers, contact manufacturer.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cn. ONE-PIECE CERTAIN MICROMINIPLANT HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ISMHA32
ISMHA33
ISMHA34
ISMHA36
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Co. CERTAIN GOLD-TITE HEXED LARGE DIAMETER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ILRGHG
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cp. GOLD-TITE SQUARE UNISCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
UNISG
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cq. GOLD-TITE HEXED RETAINING SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THA42 THA43 THA44
THA46
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cr. LOCATOR LIGHT RETENTION MALES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LLRMS
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cs. LOCATOR EXTENDED RANGE MALES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
LAERM
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ct. CERTAIN GINGIHUE POST (ABUTMENT)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMPAP352G IMPAP354G
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Cu. CERTAIN EP HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMHA352 IMHA353 IMHA354 IMHA356
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES