Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
FDA device recall Z-2645-2023 · posted 2023-09-28 · Open, Classified
Recall details
- Recalling firm
- Stryker Corporation
- Reason for recall
- Expired Product distributed
- Action taken
- 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 devices back to Stryker Endoscopy. 4. If no product is found, complete acknowledgement form and return it back to Stryker.
- Root cause
- Unknown/Undetermined by firm
- Status
- Open, Classified
- Product code
- MBI
- Quantity affected
- 96 units
- Distribution
- US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
- Date initiated
- 2023-08-23
- Date posted
- 2023-09-28
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM (K131769) | Pivot Medical, Inc. | 2013-10-07 |