FDAFDA · Food and drugs·Recall number Z-3193-2017
Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
Published October 4, 2017 · Recall initiated: May 22, 2017
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
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
- Lot
- Lot Numbers: 63545255, 63562124, 63566199, 63566218, 63584030, 63398778, 63426469, 63431693, 63431763, 63444579, 63444581, 63444582, 63444584, 63444587, 63451645, 63451647, 63451648, 63451649, 63451651, 63451655, 63462151, 63462166, 63462170, 63462174, 63474142, 63478948, 63484963, 63484966, 63484973, 63492362, 63492363, 63505347, 63505348, 63510772, 63510773 & 63524431.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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