FDA-Device2017-02-22Class II

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

Zimmer Biomet, Inc.
Hazard

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.

Sold states
Domestic: 0 Foreign: Singapore & Malaysia
Affected count
26
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2017

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