Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 25 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, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 25 units of nonsterile Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length (Item Number/EDI 00480606011). The recall involves specific lot numbers: 63550419, 63556696, 63566195, 63641526, 63326478, 63358155, 63364056, 63462112, 63474138, 63484940, 63492343, 63524330, and 6350361.
The recall was initiated because the instruments were manufactured from raw material with an anomaly. This anomaly may be on or below the surface and can increase the risk of instrument fracture. The affected products are orthopedic surgical instruments used for trauma and extremity procedures.
The products were distributed nationwide in the USA and internationally to Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan, and Trinidad. Healthcare facilities and users should stop using the affected instruments and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 25
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 (12)
- Lot Numbers: 63550419
- 63556696
- 63566195
- 63641526
- 63326478
- 63358155
- 63364056
- 63462112
- 63474138
- 63484940
- 63492343
- 63524330 & 6350361
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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