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.
Recall
- Recall Number
- Z-0131-2016
- Event Number
- 72208
- FEI Number
- 1000116912
- Product Code
- PHX
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 15, 2015
- Posted
- October 16, 2015
- Terminated
- January 10, 2017
- Address
- 9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445
Description
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.
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
The firm, DJO Global, sent an "URGENT FIELD SAFETY NOTICE" letter dated 9/16/15 to affected consignees/customers. The letter described the product, problem, and actions to be taken. The consignees/customers were instructed quarantine the device, pass the notice on to all who need to be aware within your organization, contact customer service to place a replacement order and receive an RMA number; and to complete a response form and return the recalled device for a replacement. If you have any questions, please call (512) 834-6302 or by email at [email protected].
US Distribution to states of: PA, FL, ID, and CA.
20 units