Recall Z-1726-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-1726-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-12

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-06-12, terminated 2015-09-21. It names one FDA 510(k) clearance: K060138. Product: Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.. Reason: The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Terminated: 2015-09-21
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

Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.

Reason for recall

The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.

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