Z-1234-2026 Class II Ongoing
FDA device recall Z-1234-2026 was initiated by Encore Medical, LP on Jan 5, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 49.
Recall details
- Product Type
- Devices
- Report Date
- Feb 11, 2026
- Initiation Date
- Jan 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
Product description
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
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.
Distribution pattern
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Code information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1234-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026