Z-0495-2019 Class II Terminated
FDA device recall Z-0495-2019 was initiated by Zimmer Biomet, Inc. on Oct 22, 2018 and is designated Class II. Reason for recall: Label on the outer carton or the patient labels does not match label on the inner sterile packaging The recall status is terminated (terminated Dec 11, 2019). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Oct 22, 2018
- Termination Date
- Dec 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Reason for Recall
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Distribution Pattern
AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Code Information
Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0495-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026