Device product
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Z-1296-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67733
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 32,271 ea.
- Official record key
device-enforcement:Z-1296-2014
Official wording
Reason: The products are being recalled because they did not meet minimum needle attachment strength requirements.
Code information: Product Code: X-6371M5, Lot numbers: 02E0801603
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.