Recall Z-2265-2014— Synthes, Inc.

Name: FDA recall Z-2265-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-30

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2014-06-30, terminated 2015-12-18. It names one FDA 510(k) clearance: K951304. Product: Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set. Reason: A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-30
Terminated: 2015-12-18
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K951304 — SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHERSynthes (Usa)·cleared 1995-06-16

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 3.0 MM TI Cannulated Screw Instrument and Implant Set

Reason for recall

A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.

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