FDA-Device2015-10-28Class II
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.
Encore Medical, Lp
Hazard
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Sold states
US Distribution to states of: PA, FL, ID, and CA.
Affected count
20 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2016Don't want to check this manually?
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