Recall Z-1413-2017— Encore Medical, Lp

Name: FDA recall Z-1413-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-09

Class II · Terminated

Class II FDA medical device recall by Encore Medical, Lp, initiated 2017-02-09, terminated 2017-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: RSP Impaction Fixture. Reason: 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..

Recalling firm: Encore Medical, Lp
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Terminated: 2017-10-20
Firm location: Austin, TX, United States

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.

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