ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF… recallZ-1169-2023 · Wright Medical Technology, Inc. · initiated Feb 2, 2023
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Wright Medical Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
FDA root cause category: Employee error
What the company is doing
The firm issued an URGENT MEDICAL DEVICE notice to its the sole consignee by email on 02/02/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to [email protected] to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Maintain awareness of this communication internally until all required actions have been completed within your facility.. 4. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers.
Recall details
- Recall number
- Z-1169-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 2, 2023
- Posted by the FDA
- Feb 24, 2023
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 10 units
- Product code
- HRS
- FDA submissions
- K113014
- Distribution
- US Nationwide distribution in the state of NY.
Product description
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Code information (models, lots, serial numbers)
GTIN 00840420152985, Lot Number 1636048
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ORTHOLOC 3DSi CLAW II 402S0425Wright Medical Technology, Inc. · Screw, fixation, bone1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 91673).
- Z-1170-2023 · Open, ClassifiedORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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