CHARLOTTE CLAW Screw, REF: 40122716, intended for use with… recallZ-3334-2026 · Wright Medical Technology, Inc. · initiated Aug 18, 2026
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
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
FDA root cause category: Process control
What the company is doing
On 8/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: 1) Review the product issue and risks as communicated in this Recall Notice and communicate the issue as appropriate in your organization. 2) Sign and return the enclosed business reply form by email to [email protected] 3) Upon receipt of the completed business reply form, firm will arrange for product return. 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. Inform firm if any of the subject devices have been distributed to other organizations, including contact details, so that firm can inform the recipients appropriately. b. If you are a distributor, notify your affected customers. For questions or concerns, contact the firm at [email protected]
Recall details
- Recall number
- Z-3334-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 18, 2026
- Posted by the FDA
- Oct 1, 2026
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 34
- Product code
- HRS
- FDA submissions
- K133715
- Distribution
- US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Product description
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Code information (models, lots, serial numbers)
UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CLAW CHARLOTTE 40122716Wright Medical Technology, Inc. · PLATE, FIXATION, BONE1 recall0 reports
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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