Recall Z-2049-2014 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew, Inc. Endoscopy Division
SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
| Date | Jul 14, 2014 (initiated Jun 2, 2014) |
| Status | Terminated |
| Reason | Sterility of device is compromised due to breach in sterile barrier |
| Root cause | Package design/selection |
| Action | 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 |
| Quantity | 763 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122059 | ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS Smith & Nephew, Inc., Mar 18, 2013 |