Z-0938-2019 Class II Terminated
FDA device recall Z-0938-2019 was initiated by Zimmer Biomet, Inc. on Dec 21, 2018 and is designated Class II. Reason for recall: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label. The recall status is terminated (terminated May 13, 2020). Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product Description
Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
Reason for Recall
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Distribution Pattern
MN, VA Foreign: Korea, New Zealand and Japan
Code Information
Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0938-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026