Recall Z-2240-2013 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith & Nephew, Inc. Endoscopy Division
TWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202620 Biodegradable suture anchor
| Date | Sep 17, 2013 (initiated Aug 6, 2013) |
| Status | Terminated |
| Reason | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. |
| Root cause | Packaging |
| Action | 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 the |
| Quantity | 314 US |
| Distribution | 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-pa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093844 | SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR Smith & Nephew, Inc., Apr 1, 2010 |