—#126706

Product

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

FDA product code: GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K992088
Affected lot / code info: Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.

Why it was recalled

The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax 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 - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-05-01
Terminated: 2016-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126706. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.