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TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS (2016-07-19)
- Starting date:
- July 19, 2016
- Posting date:
- July 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59626
Affected products
A. TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS
Reason
Smith & Nephew Inc. has initiated a field correction of various lots of the TRIGEN Internal Hexrecon screw due to a packaging error. Based on internal evaluation, various lots of the screws were distributed with an incorrect IFU. The fracture fixation IFU was packaged with the device instead of the correct IFU, intramedullary nail system
Affected products
A. TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
71642365
Companies
- Manufacturer
-
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES