EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
FDA Recall Z-0125-2023 · Posted 2022-10-21
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Recalling FirmEncore Medical, LP
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2022-08-12
Product Quantity4
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.
Firm Action
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]
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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