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U.S. Department of Health and Human Services

Class 2 Device Recall CHARLOTTE CLAW Screw

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 Class 2 Device Recall CHARLOTTE CLAW Screwsee related information
Date Initiated by FirmAugust 18, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3334-2026
Recall Event ID 99651
510(K)NumberK133715 
Product Classification Plate, fixation, bone - Product Code HRS
ProductCHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Code Information UDI-DI: 00840420109705, Lot: 1826666, Distributed: 18-Aug-2025 through 09-Apr-2026
FEI Number 3010667733
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
11500 memphis arlington rd
arlington TN 38117-5423
For Additional Information ContactMeghan Wells
901-201-9298
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce34
DistributionUS Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRS
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