Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Reported: February 22, 2017 Initiated: December 15, 2016 #Z-1219-2017
Product Description
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
Reason for Recall
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 26
- Distribution
- Domestic: 0 Foreign: Singapore & Malaysia
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265. Recalled by Zimmer Biomet, Inc.. Units affected: 26.
Why was this product recalled? ▼
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1219-2017.
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