—#121352

Product

TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue; Part Number: 72202597 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: 50324706 50324707 50324958 50325148 50326624 50336118 50336716 50336759 50337105 50337109 50337112 50339394 50339648 50339653 50339656 50339873 50341613 50343278 50344410 50346095 50350419 50352199 50357080 50358106 50358736 50359998 50361739 50362786 50363871 50366812 50368582 50370504 50372042 50374257 50376594 50378774 50380528 50382637 50384518 50386924 50388022 50390005 50390988 50392388 50395082 50395975 50396667 50398098 50401255 50402220 50404745 50406626 50406675 50408537 50411606 50414330 50415861 50417004 50418086 50422213 50428616 50429266 50429632 50436702 50436747 50436748 50438319 50438651 50438735 50438739 50438918 50445013 50446067 50446068 50446460 50446995 50448591 50450274 50451213 50453452 50453995 50456041 50456190 50457051 50458600 50462057

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 #121352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.