—#128227

Product

SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K122059
Affected lot / code info: Lot Numbers: 50477397, 50481448

Why it was recalled

Sterility of device is compromised due to breach in sterile barrier

Root cause (FDA determination)

Package design/selection

Action the firm took

Smith & Nephew issued an Urgent - Product Recall Notification letter dated June 2, 2014 via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and locate all affected product and quarantine them immediately. Complete the Return Certification Form . Contact the Smith & Nephew Returns Group at 800-343-5717 (option 3) or send an email to ProductRecoverv@smith-nephew.com. They will provide customers with instructions for returning their product and receiving a replacement. For questions regardin g this recall call 978-749-1073.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

Timeline

Recall initiated: 2014-06-02
Posted by FDA: 2014-07-14
Terminated: 2017-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128227. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.