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Encore Medical, Lp recalls AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless applicat
Recalled October 28, 2015 · FDA recall Z-0131-2016 · Encore Medical
Hazard
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. · FDA Class II
Units
20 units
Sold at
US Distribution to states of: PA, FL, ID, and CA.
Description
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Product
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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →