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Terminated

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument

FDA Recall Z-0867-2017 · Posted 2016-12-21

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeFSM
Date Initiated2016-11-29
Date Terminated2017-08-03
Product Quantity31 units

Reason for Recall

The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Firm Action

DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: [email protected] or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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