Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps 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 701 units of Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length (Item Number/EDI 00480610027, Nonsterile) and various other trauma and extremity instruments, including screw taps. 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 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 lot numbers are 63545256, 63550424, 63457944, 63462196, 63462201, 63469886, 63474144, 63484983, 63492364, 63496869, 63505349, 63510774, and 63530385.
Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the recalled instruments are found, they should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 701
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: 63545256
- 63550424
- 63457944
- 63462196
- 63462201
- 63469886
- 63474144
- 63484983
- 63492364
- 63496869
- 63505349
- 63510774 & 63530385.
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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