—#126185

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.

FDA product code: GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K021019
Affected lot / code info: Product Code: X-6371M5, Lot numbers: 02E0801603

Why it was recalled

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Root cause (FDA determination)

Employee error

Action the firm took

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

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-03-26
Terminated: 2017-08-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126185. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.