Recall Z-2645-2023
Stryker Corporation · initiated August 23, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Codes / lots: Lot # 19175AE2
Reason for recall
Expired Product distributed
FDA-determined cause: Unknown/Undetermined by firm
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.
Details
- Recall number
- Z-2645-2023
- Initiated
- August 23, 2023
- Posted by FDA
- September 28, 2023
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 96 units
- Distribution
- US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
- Recalling firm
- Stryker Corporation, San Jose, CA