Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Reported: October 3, 2018 Initiated: August 2, 2018 #Z-3249-2018
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 16
- Distribution
- Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty. Recalled by Zimmer Biomet, Inc.. Units affected: 16.
Why was this product recalled? ▼
The implant only has one bolt in the sterile package but it should have had two.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3249-2018.
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