Encore Medical, Lp recalls Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the

Recalled November 4, 2015 · FDA recall Z-0180-2016 · Encore Medical

Hazard

During the 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. · FDA Class II

Units

634 units

Sold at

Nationwide Distribution

Description

During the 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.

Product

Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck construct. The RSP Fixture is used to assemble the UHMWPE Socket Inserts to both the RSP Socket Shells and Monoblock Stems.

Manufacturer(s)

Encore Medical, Lp

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →