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Open, Classified

CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System

FDA Recall Z-3334-2026 · Posted 2026-10-01

Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2026-08-18
Product Quantity34

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.

Firm Action

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]

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN, NJ, WI, CO.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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