Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating SystemUDI-DIUDI-DI 008404201097053 affected lots182666618-Aug-202509-Apr-2026
What the firm 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 memphis.fieldaction@stryker.com 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 memphis.fieldaction@stryker.com
DistributionShow detailsHide
US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3334-2026
- FDA 510(k) clearance · K133715The device's official FDA premarket clearance record
- FDA device classification · HRSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3030The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Wright Medical Technology, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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