Recall Z-2243-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-2243-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-18

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-04-18, terminated 2015-03-30. It names one FDA 510(k) clearance: K970733. Product: Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.. Reason: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-04-18
Terminated: 2015-03-30
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K970733 — SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa)·cleared 1997-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.