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Trigen Titanium Nail System - Intertan Short Nails (2014-04-07)
- Starting date:
- April 7, 2014
- Posting date:
- June 5, 2014
- 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-39803
Recalled products
Trigen Titanium Nail System - Intertan Short Nails
Reason
Smith & Nephew has initiated a product recall of several batches of the Trigen Intertan nail due to a manufacturing error, which resulted in the set screw being set too deep in the affected nails. During implantation, when the proximal femur is being reamed to accept the lag and compression screw, the reamer may impinge the set screw, causing potential breakage of the reamer.
Affected products
Trigen Titanium Nail System - Intertan Short Nails
Lot or serial number
- 13LT36306
- 13LT36308
- 13LT36313
- 13LT36398
- 13LT37010
- 13LT37012
Model or catalog number
- 71675201
- 71675202
- 71675204
- 71675205
- 71675211
Companies
- Manufacturer
-
Smith and Nephew, Inc.
1450 Brooks Road
Memphis
38116
Tennessee
UNITED STATES