Recall Z-2645-2023 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Corporation
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
| Date | Sep 28, 2023 (initiated Aug 23, 2023) |
| Status | Open, Classified |
| Reason | Expired Product distributed |
| Root cause | Unknown/Undetermined by firm |
| Action | On August 23, 2023, Stryker issued an "Urgent Medical Device Recall Notification" to affected consignees via . Stryker asked consignees to take the following actions: Actions needed: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all inventory to determine if any devices from the affected product list are located at your facility. Response is required by September 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the response form on Appendix A of this notice and return devic |
| Quantity | 96 units |
| Distribution | US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131769 | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM Pivot Medical, Inc., Oct 7, 2013 |