—#121357

Product

TWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626 Biodegradable suture anchor

FDA product code: MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K093844
Affected lot / code info: 50324715 50324960 50326833 50336719 50336768 50339643 50339651 50341854 50344396 50348650 50349838 50350841 50351449 50353295 50360151 50363875 50368586 50372045 50374017 50375716 50378770 50381624 50387868 50390937 50395330 50397700 50402973 50404638 50406692 50408058 50412954 50415137 50416799 50418989 50429269 50429640 50429642 50429832 50431134 50439753 50439754 50442740 50443625

Why it was recalled

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Root cause (FDA determination)

Packaging

Action the firm took

Smith&Nephew sent an Urgent Product Recall Notification letter dated August 6, 2013, via Federal Express to all affected customers. Addendum customer letters for 4 additional part numbers were sent via Federal Express on August 19, 2013, The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to inspect their inventory, locate unused devices and quarantine them. Customers were also asked to complete the last three columns in the inventory Return Certification form indicating the quantities that need to be returned, and include their contact information in the spaces provided. Customers were instructed to contact Smith & Nephew's Demo Service Departmentat 800-343-5717 for a Return Authorization (RA#), and provide the information response form. Replacement product would be provided. For questions regarding 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) Canada, Europe: Austria, Belgium, Cyprus, Czech Republic, Denmark, Germany, Greece, Finland, France, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine and United Kingdom, Asia-pacific: Australia, China, Dubai, Hong Kong, India, Japan, Malaysia, New Zealand, Philippines, Sri Lanka, Singapore, South Korea, Taiwan, Thailand, Argentina, Bermuda, Brazil, Chile, Colombia, Costa Rica, Israel, Mexico, Puerto Rico, South Africa, and Venezuela.

Timeline

Recall initiated: 2013-08-06
Posted by FDA: 2013-09-17
Terminated: 2016-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121357. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.