FDA DevicesClass II
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; L...
Published: February 11, 2026Recall ID: Z-1234-2026Category: devicesCountry: US
Reason for Recall / Hazard
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Product Description & Identification
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Affected Products
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98177 |
| Address 1 | 9800 Metric Blvd |
| Address 2 | N/A |
| Code info | REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026), 942-01-36J/00190446309802/626Z1021(03-15-2026), 942-01-40G/00190446309826/628Z1034(03-15-2026), 942-01-32C/00190446309697/615Z1026(03-15-2026) |
| Postal code | 78758-5445 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 49 |
| Reason for recall | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260105 |
| Initial firm notification | N/A |
| Center classification date | 20260202 |
Overview
- Recalling FirmEncore Medical, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA