Z-1233-2026 Class II Ongoing
FDA device recall Z-1233-2026 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: 19.
Recall details
- Product Type
- Devices
- Report Date
- Feb 11, 2026
- Initiation Date
- Jan 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
Product description
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
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
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1233-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026