Recall Z-1536-2018 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith & Nephew, Inc.
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
| Date | Dec 11, 2017 |
| Status | Terminated |
| Reason | Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed. |
| Root cause | Employee error |
| Action | On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at FieldActions@smith-nephew.com |
| Quantity | 22 |
| Distribution | Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952535 | ACUFEX ENDOBUTTON TAPE Acufex Microsurgical, Inc., Feb 8, 1996 |