Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 75 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of instrument fracture, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 75 units of the Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length (Item Number/EDI 00480619532). These nonsterile orthopedic surgical instruments 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 was initiated because various trauma and extremity instruments, including these 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. The affected lot numbers are 63570253, 63574369, 63584044, 63622717, and 63634109.
Healthcare providers and facilities should stop using these specific instruments and contact Zimmer Biomet for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 75
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 (4)
- Lot Numbers: 63570253
- 63574369
- 63584044
- 63622717 & 63634109.
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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