Recall Z-2745-2016 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
| Date | Jul 19, 2016 |
| Status | Terminated |
| Reason | Sterility compromised due to breach in sterile packaging |
| Root cause | Package design/selection |
| Action | Smith & Nephew issued recall letters via Federal Express on July 19, 2016 to the customers. Customers asked to inspect inventory and locate any unused devices, and quarantine immediately. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. |
| Quantity | 34,065 units |
| Distribution | Worldwide distribution. US nationwide, and the countries of: AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952535 | ACUFEX ENDOBUTTON TAPE Acufex Microsurgical, Inc., Feb 8, 1996 |