FDAFDA · Food and drugs·Recall number Z-1219-2017
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
Published February 22, 2017 · Recall initiated: December 15, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Domestic: 0 Foreign: Singapore & Malaysia
- Lot
- 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; Lot No's: ZB160701, ZB160702, ZB160703, ZB160701, ZB160702, ZB160701, ZB160702, ZB160703, ZB160801, ZB160802, ZB160803, ZB160801, ZB160802
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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