EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H… recallZ-0125-2023 · Encore Medical, LP · initiated Aug 12, 2022
Open, Classified
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
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
FDA root cause category: Process control
What the company is doing
On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: [email protected]
Recall details
- Recall number
- Z-0125-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2022
- Posted by the FDA
- Oct 21, 2022
- Recalling firm
- Encore Medical, LP
- Quantity
- 4
- Product code
- LPH
- FDA submissions
- K190057
- Distribution
- US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Product description
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Code information (models, lots, serial numbers)
UDI-DI/Lot: 00190446309833/629Z1085
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
Other devices under the same FDA submission
73 devices cleared under K190057 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DJO SURGICAL 942-01-40GEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall17 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- DJO SURGICAL 941-01-36EEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED44 reports
- DJO SURGICAL 941-01-40HEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED35 reports
- DJO SURGICAL 941-01-40GEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED34 reports
- DJO SURGICAL 941-01-36FEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED30 reports
- DJO SURGICAL 940-02-50EEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED26 reports
- DJO SURGICAL 940-02-52FEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented22 reports
- DJO SURGICAL 940-02-54GEncore Medical, L.P. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED19 reports
- DJO SURGICAL 941-01-36GEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented18 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90882).
- Z-0126-2023 · Open, ClassifiedEMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
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 16, 2026. Text above is shown as published by the FDA.
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