Z-0626-2024 Class II
FDA device recall Z-0626-2024 was initiated by Encore Medical, LP on Oct 5, 2023 and is designated Class II. Reason for recall: Mislabeling Affected quantity: 2 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 10, 2024
- Initiation Date
- Oct 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product description
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Reason for recall
Mislabeling
Distribution pattern
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Code information
UDI: (01)00888912108560/Lot Number(s): 157N1556
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0626-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026