EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
FDA device recall Z-0125-2023 · posted 2022-10-21 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- 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.
- Action taken
- 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: Julie.Baker@Enovis.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LPH
- Quantity affected
- 4
- Distribution
- US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
- Date initiated
- 2022-08-12
- Date posted
- 2022-10-21
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DJO Acetabular System (K190057) | Encore Medical L.P. | 2019-06-07 |