AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL… recallZ-1241-2018 · Encore Medical, Lp · initiated Jan 30, 2018
Class II Terminated All recalls posted in March 2018
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
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
FDA root cause category: Device Design
What the company is doing
The firm disseminated their field safety notices on 01/30/2018 by email. The letter identified the affected product, problem and actions to be taken. The notices requested the trails be returned for replacement.
Recall details
- Recall number
- Z-1241-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 30, 2018
- Posted by the FDA
- Mar 5, 2018
- Recalling firm
- Encore Medical, Lp
- Quantity
- 387 units
- Product code
- PHX
- FDA submissions
- K141990
- Distribution
- US Nationwide Distribution
Product description
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to the humeral broaches by a screw in order to replicate/trial the entire humeral stem implant geometry prior to implantation.
Code information (models, lots, serial numbers)
Lot Codes: 183312L03, 200006L01, 224643L01
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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