EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Reported: November 2, 2022 Initiated: August 12, 2022 #Z-0125-2023
Product Description
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
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.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 4
- Distribution
- US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.. Recalled by Encore Medical, LP. Units affected: 4.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0125-2023.
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