Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because a raw material anomaly may increase the risk of instrument fracture during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (raw material anomaly) in a surgical instrument that increases the risk of fracture, which poses a significant risk of injury to patients during orthopedic procedures.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,585 units of Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length (Item Number/EDI 00480610020, Nonsterile) and various other trauma and extremity instruments, including screw taps. The recall is due to a raw material anomaly that may be on or below the surface of the instruments. This anomaly can increase the risk of instrument fracture.
The affected products were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan, and Trinidad. The recall covers specific lot numbers, including 63545255, 63562124, and 63566199, among others.
Healthcare providers and facilities should check their inventory for the affected item numbers and lot numbers. If the recalled instruments are found, they should be removed from service and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2,585
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 63545255
- 63562124
- 63566199
- 63566218
- 63584030
- 63398778
- 63426469
- 63431693
- 63431763
- 63444579
- 63444581
- 63444582
- 63444584
- 63444587
- 63451645
- 63451647
- 63451648
- 63451649
- 63451651
- 63451655
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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