AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 recallZ-0131-2016 · Encore Medical, Lp · initiated Sep 15, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.
FDA root cause category: Device Design
What the company is doing
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].
Recall details
- Recall number
- Z-0131-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 15, 2015
- Posted by the FDA
- Oct 16, 2015
- Recalling firm
- Encore Medical, Lp
- Quantity
- 20 units
- Product code
- PHX
- FDA submissions
- K141990
- Distribution
- US Distribution to states of: PA, FL, ID, and CA.
Product 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.
Code information (models, lots, serial numbers)
Lot: 180052L01
Other devices under the same FDA submission
12 devices cleared under K141990 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 530-10-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented38 reports
- DJO SURGICAL 530-08-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented36 reports
- DJO SURGICAL 530-12-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented28 reports
- DJO SURGICAL 530-14-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented16 reports
- DJO SURGICAL 530-06-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented14 reports
- DJO SURGICAL 530-06-175Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented7 reports
- DJO SURGICAL 530-12-175Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented7 reports
- DJO SURGICAL 530-10-175Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- DJO SURGICAL 530-08-175Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented4 reports
- DJO SURGICAL 530-16-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented4 reports
- DJO SURGICAL 530-18-108Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented3 reports
- DJO SURGICAL 530-10-220Encore Medical, L.P. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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