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.
This recall has been terminated (originally issued March 26, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- March 26, 2014
- Terminated
- August 15, 2017
- Recall Number
- Z-1296-2014
- Quantity
- Total 32,271 ea.
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Distribution
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Lot / Code Info
Product Code: X-6371M5, Lot numbers: 02E0801603
Root Cause
Employee error
Action Taken
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990