Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific 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 involves a risk-of-harm product (instrument fracture) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,550 units of Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. These 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 is due to an anomaly in the raw material used to manufacture the instruments. This anomaly may be on or below the surface and can increase the risk of the instrument fracturing. The affected lot numbers are 63545257, 63545258, 63451724, 63451725, 63451728, 63451730, 63451744, 63451747, 63451751, 63451753, 63451754, 63462227, 63478968, 63478972, 63478974, 63485102, 63530392, and 63530394.
Healthcare facilities and users should stop using these specific drill bits and contact Zimmer Biomet for instructions on returning the affected units.
The recalled product
- Product
- Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,550
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 (17)
- Lot Numbers: 63545257
- 63545258
- 63451724
- 63451725
- 63451728
- 63451730
- 63451744
- 63451747
- 63451751
- 63451753
- 63451754
- 63462227
- 63478968
- 63478972
- 63478974
- 63485102
- 63530392 & 63530394.
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.
See all 60 products in this recall →Related recalls
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