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Terminated

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set

FDA Recall Z-2246-2018 · Posted None

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeFSM
Date Initiated2018-03-05
Date Terminated2020-02-28
Product Quantity4

Reason for Recall

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Firm Action

On March 8, 2018, the recalling firm sent Urgent Product Recall letters to its customers to inform them of the recall. Customers were advised to take the following actions: 1. Immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. 2. Complete the Verification Section and send a copy to the recalling firm. 3. Forward this notice to anyone in the facility that needs to be informed. 4. If any of the affected products have been forwarded to another facility, contact that facility to arrange return. Customers with questions were advised to call 610-719-5450, 8AM-5PM (EST), Monday through Friday, or contact their DePuy Synthes sales consultant.

Root Cause

Process control

Distribution Pattern

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

Official Source

View FDA Recall →

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

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