Recall Z-2051-2015— Synthes, Inc.

Name: FDA recall Z-2051-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-03

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2015-06-03, terminated 2015-09-15. It names one FDA 510(k) clearance: K040762. Product: TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.. Reason: A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Terminated: 2015-09-15
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K040762 — SYNTHES (USA) TIBIAL NAIL SYSTEM EXSynthes (Usa)·cleared 2004-04-12

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

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Reason for recall

A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

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