Home / Recalls / Encore Medical, Lp / Z-1413-2017

Z-1413-2017 Class II Terminated

Recalled by Encore Medical, Lp — Austin, TX

Recall Details

Product Type
Devices
Report Date
March 15, 2017
Initiation Date
February 9, 2017
Termination Date
October 20, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
626 units

Product Description

RSP Impaction Fixture

Reason for Recall

During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

Distribution Pattern

US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Code Information

109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02

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