Recall Z-0905-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-0905-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-08-31. It names one FDA 510(k) clearance: K010690. Product: Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.. Reason: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K010690 — SYNTHES TITANIUM MULTI-VECTOR DISTRACTORSynthes (Usa)·cleared 2001-05-18

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 Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

Reason for recall

It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

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