Suture-Based Repair Systems (2020-09-10)
- Starting date:
- September 10, 2020
- Posting date:
- September 25, 2020
- 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-74017
Last updated:
2020-09-25
Affected Products
- OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES
- OSTEORAPTOR 2.9 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
- OSTEORAPTOR 2.3 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
- TWINFIX AB 6.5 SUTURE ANCHOR WITH NEEDLES
- FAST-FIX AB CURVED NEEDLE MENISCAL REPAIR SYSTEM WITH SUTURE BAR
- RAPTORMITE 3.7 AB W/NEEDLES AND TWO #0 ULTRABRAID, WHITE AND COBRAID BLUE
- TWINFIX ULTRA HA SUTURE ANCHOR W/THREE ULTRABRAID SUTURES
- OSTERAPTOR CURVED 2.3 SUTURE ANCHOR
- TWINFIX ULTRA HA 4.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
- TWINFIX ULTRA HA 5.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
- HEALICOIL REGENESORB SUTURE ANCHOR
- HEALICOIL REGENESORB SUTURE ANCHOR WITH ONE ULTRATAPE AND ONE ULTRABRAID SUTURE
Reason
Smith & Nephew, Inc. has initiated a field action to voluntarily remove certain lots from the group of Suture-Based Repair Systems. Issue identified in the product packaging process may result in an improper or incomplete seal of the pouch surrounding the sterile product.
Affected products
A. OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72201995
- 72201996
- 72202165
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
B. OSTEORAPTOR 2.9 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
72201994
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
C. OSTEORAPTOR 2.3 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72201991
- 72201992
- 72201993
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
D. TWINFIX AB 6.5 SUTURE ANCHOR WITH NEEDLES
Lot or serial number
- 2025178
- 2025362
- 2040057
Model or catalog number
7210710
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
E. FAST-FIX AB CURVED NEEDLE MENISCAL REPAIR SYSTEM WITH SUTURE BAR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
72201494
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
F. RAPTORMITE 3.7 AB W/NEEDLES AND TWO #0 ULTRABRAID, WHITE AND COBRAID BLUE
Lot or serial number
- 2025354
- 2031116
- 2040066
- 2040702
- 2042557
- 2049638
- 2053749
- 2055239
Model or catalog number
72201805
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
G. TWINFIX ULTRA HA SUTURE ANCHOR W/THREE ULTRABRAID SUTURES
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72202602
- 72202608
- 72202626
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
H. OSTERAPTOR CURVED 2.3 SUTURE ANCHOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
72203290
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
I. TWINFIX ULTRA HA 4.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
Lot or serial number
- 2027487
- 2031136
- 2033257
- 2034471
- 2038440
- 2050957
- 2053792
- 2056056
Model or catalog number
72202612
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
J. TWINFIX ULTRA HA 5.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
Lot or serial number
- 2027489
- 2056058
- 2025074
- 2031006
- 2042572
- 2052109
Model or catalog number
72202616
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
K. HEALICOIL REGENESORB SUTURE ANCHOR
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72203704
- 72203706
- 72203707
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
L. HEALICOIL REGENESORB SUTURE ANCHOR WITH ONE ULTRATAPE AND ONE ULTRABRAID SUTURE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 72203697
- 72203705
- 72203708
- 72203801
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES