Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 155 orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to 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 in the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 155 units of nonsterile orthopedic surgical instruments, specifically Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length (Item Number/EDI 00480507015). The recall covers various trauma and extremity instruments, including drill bits and screw taps, distributed nationwide in the United States and internationally to 17 countries including Australia, Brazil, Canada, and Germany.
The recall was initiated because the instruments were manufactured from raw material with an anomaly. This anomaly may be located on or below the surface of the instrument and can increase the risk of the instrument fracturing during use. The affected lot numbers are 63550419, 63556696, 63566195, 63641526, 63326478, 63358155, 63364056, 63462112, 63474138, 63484940, 63492343, 63524330, and 6350361.
Healthcare providers and facilities that have received these products should stop using them immediately and contact Zimmer Biomet for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 155
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.
See all 60 products in this recall →Related recalls
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