TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Reported: July 29, 2020 Initiated: June 24, 2020 #Z-2685-2020
Product Description
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Reason for Recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 12 units
- Distribution
- International distribution in the countries of Brazil, Colombia and United Arab Emirates.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.. Recalled by Smith & Nephew, Inc.. Units affected: 12 units.
Why was this product recalled? ▼
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2685-2020.
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