Z-3249-2018 Class II Terminated
FDA device recall Z-3249-2018 was initiated by Zimmer Biomet, Inc. on Aug 2, 2018 and is designated Class II. Reason for recall: The implant only has one bolt in the sterile package but it should have had two. The recall status is terminated (terminated Apr 25, 2019). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Aug 2, 2018
- Termination Date
- Apr 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Reason for Recall
The implant only has one bolt in the sterile package but it should have had two.
Distribution Pattern
Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Code Information
Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3249-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026