Device 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.
Z-0131-2016
Product summary
- Event
- Event 72208
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0131-2016
Official wording
Reason: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
Code information: Lot: 180052L01
Distribution pattern: US Distribution to states of: PA, FL, ID, and CA.
Derived failure modes
-
Unknown
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.