Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
FDA Recall Z-2645-2023 · Posted 2023-09-28
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Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeMBI
Date Initiated2023-08-23
Product Quantity96 units
Reason for Recall
Expired Product distributed
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 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
Distribution Pattern
US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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