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Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 recallZ-2645-2023 · Stryker Corporation · initiated Aug 23, 2023

Class II Open, Classified All recalls posted in September 2023

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Expired Product distributed

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

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.

Recall details

Recall number
Z-2645-2023
Recall class
Class II
Status
Open, Classified
Initiated by the company
Aug 23, 2023
Posted by the FDA
Sep 28, 2023
Recalling firm
Stryker Corporation
Quantity
96 units
Product code
MBI
FDA submissions
K131769
Distribution
US Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.

Product description

Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

Code information (models, lots, serial numbers)

Lot # 19175AE2

Other devices under the same FDA submission

4 devices cleared under K131769 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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