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Terminated

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.

FDA Recall Z-2243-2013 · Posted 2013-09-18

Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHTY
Date Initiated2013-04-18
Date Terminated2015-03-30
Product Quantity1

Reason for Recall

Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.

Firm Action

A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.

Root Cause

Packaging process control

Distribution Pattern

US distribution to MA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970733SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa) · 1997-04-02

Official Source

View FDA Recall →

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

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