Home / Recalls / Synthes USA HQ, Inc. / Z-0394-2014

Z-0394-2014 Class II Terminated

Recalled by Synthes USA HQ, Inc. — West Chester, PA

Recall Details

Product Type
Devices
Report Date
December 4, 2013
Initiation Date
October 3, 2013
Termination Date
December 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3087

Product Description

Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Reason for Recall

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Distribution Pattern

Nationwide Distribution

Code Information

part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

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