AltiVate Reverse Humeral Broach, Size 10 Catalog number… recallZ-0626-2016 · Encore Medical, Lp · initiated Dec 8, 2015
Class II Terminated All recalls posted in January 2016
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
The trial shell mating feature on the broach is undersized.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm notified customers of the recall via letter on 12/8/15.
Recall details
- Recall number
- Z-0626-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 8, 2015
- Posted by the FDA
- Jan 9, 2016
- Recalling firm
- Encore Medical, Lp
- Quantity
- 23 units
- Product code
- PHX
- FDA submissions
- K141990
- Distribution
- Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Product description
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.
Code information (models, lots, serial numbers)
178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06
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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