Recall Z-2148-2014— Synthes, Inc.

Name: FDA recall Z-2148-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-16

Class I · Terminated

Class I FDA medical device recall by Synthes, Inc., initiated 2014-04-16, terminated 2015-09-09. It names one FDA 510(k) clearance: K060138. Product: DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies). Reason: DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively..

Recalling firm: Synthes, Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-04-16
Terminated: 2015-09-09
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K060138 — SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEMSynthes (Usa)·cleared 2006-06-02

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

DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

Reason for recall

DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

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