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Terminated

TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

FDA Recall Z-1600-2015 · Posted 2015-05-12

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-04-09
Date Terminated2016-08-18
Product Quantity8175

Reason for Recall

TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.

Firm Action

An urgent Field Safety Notification, dated April 9, 2015, was sent to end users and sales consultants to alert them about the issue and request that they take the following actions: 1) review the instructions listed in this notification; 2) forward this notice to anyone in your facility that needs to be informed; and 3) complete the attached Verification Section (page 4 of this notification) and send a copy of the completed Verification Section by: Fax: (888) 446-5160 or Scan/email: [email protected].

Root Cause

Process control

Distribution Pattern

Distribution US Nationwide and Switzerland.

Official Source

View FDA Recall →

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

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