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Various Medical Devices Recalled by Biomet 3i (2015-11-30), Part 1
- 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-56658
Affected Products
- Aa. GOLD SCREW
- Ab. O-RING ABUTMENT
- Ac. ONE-PIECE HEALING ABUTMENTS
- Ad. HEALING ABUTMENTS
- Ae. 2 PIECE ABUTMENTS - TITANIUM
- Af. CERTAIN ENCODE 2-PC EP HEALING ABUTMENT
- Ag. ENCODE 2-PC EP HEALING ABUTMENT
- Ah. DRILL STOPS
- Ai. CERTAIN MICROMINIPLANT CONICAL ABUTMENT
- Aj. CONICAL ABUTMENT SET
- Ak. DAL-RO ABUTMENT SET
- Am. CERTAIN TEMPORARY CYLINDER WITH RETENTION SETS
- An. CERTAIN MICROMINIPLANT TEMP CYLINDER WITH TITANIUM
- Ao. TEMPORARY CYLINDER WITH RETENTION
- Ap. CERTAIN TITANIUM HEXED SCREW
- Aq. CERTAIN TITANIUM HEXED UNISCREW
- Ar. TITANIUM HEXED SCREW
- As. TITANIUM SQUARE UNISCREW
- At. DISTAL EXTENTION
- Au. GINGIHUE POSTS - TEMP
- Av. CERTAIN PROVIDE ABUTMENT - TEMP
- Aw. IOL TEMPORARY CYLINDER
- Ax. TEMP HEALING RETENTION CYLINDER
- Ay. HEADLESS COVER SCREW
- Az. CERTAIN IMPLANT HEADLESS COVER SCREW
- Ba. IMPLANT COVER SCREW
- Bb. CERTAIN IMPLANT COVER SCREW
- Bc. CERTAIN MICROMINIPLANT COVER SCREW
- Bd. MICROMINIPLANT COVER SCREW
- Be. CONICAL EP HEALING CAP
- Bf. IOL HEALING CAP
- Bg. MICROMINI CONICAL HEALING CAP
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
Aa. GOLD SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
GSH30
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ab. O-RING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
OSO40 OSO60
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ac. ONE-PIECE HEALING ABUTMENTS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MHA32
MHA33
MHA34
MHA36
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ad. HEALING ABUTMENTS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THA58
THA63
THA64
THA66
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ae. 2 PIECE ABUTMENTS - TITANIUM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IOL55T
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Af. CERTAIN ENCODE 2-PC EP 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
Ag. ENCODE 2-PC EP HEALING ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
Plus de 10 numéros, contactez le fabricant.
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ah. DRILL STOPS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DS2310 DS2315
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ai. CERTAIN MICROMINIPLANT CONICAL ABUTMENT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMCA31 IMCA33
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Aj. CONICAL ABUTMENT SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
WCA51
WCA52
WCA53
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ak. DAL-RO ABUTMENT SET
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DRH20 DRH40 DRH60
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Am. CERTAIN TEMPORARY CYLINDER WITH RETENTION SETS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IWTCS41
IWTCS51
IWTCS61
IWTCS62
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
An. CERTAIN MICROMINIPLANT TEMP CYLINDER WITH TITANIUM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMMTCS1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ao. TEMPORARY CYLINDER WITH RETENTION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMTCS1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ap. CERTAIN TITANIUM HEXED SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ILRGHT
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Aq. CERTAIN TITANIUM HEXED UNISCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SCRSBL1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ar. TITANIUM HEXED SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
UNIHT
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
As. TITANIUM SQUARE UNISCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
UNIST
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
At. DISTAL EXTENTION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IOLDE
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
At. DISTAL EXTENTION
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IOLDE
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Au. GINGIHUE POSTS - TEMP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MAP32G MAP34G
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Av. CERTAIN PROVIDE ABUTMENT - TEMP
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
Aw. IOL TEMPORARY CYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IOLTC
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ax. TEMP HEALING RETENTION CYLINDER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
THRC4
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ay. HEADLESS COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CS275
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Az. CERTAIN IMPLANT HEADLESS COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ICSF41 ICSF50 ICSF60
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Ba. IMPLANT COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CS375
CS500
Bb. CERTAIN IMPLANT COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ICS375 ICS500
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bc. CERTAIN MICROMINIPLANT COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IMMCS1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bd. MICROMINIPLANT COVER SCREW
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MMCS1
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Be. CONICAL EP HEALING CAP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CS250
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bf. IOL HEALING CAP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
IOLHC
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES
Bg. MICROMINI CONICAL HEALING CAP
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MHC33
Companies
- Manufacturer
-
BioMet 3I, also trading as Implant Innovations Inc.
4555 RIVERSIDE DRIVE
Palm Beach Gardens
33410
Florida
UNITED STATES