Device product
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation.
Z-1291-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67733
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 32,271 ea.
- Official record key
device-enforcement:Z-1291-2014
Official wording
Reason: The products are being recalled because they did not meet minimum needle attachment strength requirements.
Code information: Product Code: 1154654, Lot number: 02K0801212
Distribution pattern: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Derived failure modes
-
Unknown
The products are being recalled because they did not meet minimum needle attachment strength requirements.