device · product 1 of 6
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.
- Recall number
- Z-1291-2014
- Initiated
- March 11, 2014
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Teleflex Medical
- Quantity
- Total 32,271 ea.
App-derived interpretation
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Official device-enrichment evidence · Sourced
Employee error
Inspect official wording and provenance
Reason for recall
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