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COCR Modular Neck Components, SMF Hip Stem Systems, and Redapt Femoral Systems (2016-11-17)
- Starting date:
- November 17, 2016
- Posting date:
- December 5, 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-61316
Affected Products
A. COCR Modular Neck Components - Modular Neck High Offset
B. COCR Modular Neck Components - Modular Neck Standard Offset
C. COCR Modular Neck COCR Modular Neck Components - Neck Anteverted
D. SMF Hip Stem System - Stem with Stiktite
E. SMF Hip Stem System - Stem RSA
F. Redapt Revision Femoral System Proximally Fluted Revision Stem
G. Redapt Revision Femoral System Modular Sleeved Revision
Reason
During a recent review of product complaints and clinical study data associated with the modular hip prostheses, a higher rate of complaints was observed in comparison with the comparable monolithic hip prostheses.
Affected products
A. COCR Modular Neck Components - Modular Neck High Offset
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71352112
71354061
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
B. COCR Modular Neck Components - Modular Neck Standard Offset
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71352111
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
C. COCR Modular Neck COCR Modular Neck Components - Neck Anteverted
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71352116
71352117
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
D. SMF Hip Stem System - Stem with Stiktite
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71352501
71352502
71352503
71352504
71352505
71352506
71352507
71352508
71352509
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
E. SMF Hip Stem System - Stem RSA
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71352401
71352402
71352403
71352404
71352405
71352406
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
F. Redapt Revision Femoral System Proximally Fluted Revision Stem
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71354312
71354313
71354314
71354315
71354316
71354317
71354318
71354319
71354320
71354321
71354322
71354323
71354324
71354325
71354326
71354327
71354328
71354329
71354330
71354331
71354332
71354333
71354334
71354335
71354336
71354337
71354338
71354339
71354340
71354341
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES
G. Redapt Revision Femoral System Modular Sleeved Revision
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71354334
71354335
71354336
71354337
71354338
71354339
71354340
71354341
71354360
71354361
71354362
71354363
71354364
71354365
71354366
71354367
71354368
71354369
71354370
71354371
71354372
71354374
71354375
71354376
71354377
71354378
71354379
71354380
71354381
71354382
71354383
71354384
71354385
71354386
71354387
71354388
71354389
71354404
71354405
71354407
71354408
71354409
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis
38116
UNITED STATES