Encore Medical, Lp recalls AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless applicatio…

Recall date

September 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0131-2016

FDA classification

Class II

Brand / firm

Encore Medical, Lp

Sold / distributed

US Distribution to states of: PA, FL, ID, and CA.

Why it was recalled

Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder reconstructive surgery should be reserved for patients who have failed non-operative treatments.