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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a risk of instrument fracture (a structural defect) is assigned a score of 4 (Severe).
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,154 units of Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length (Item Number/EDI 00480611035) and various other trauma and extremity instruments, including screw taps. The recall is classified as FDA Class II.
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 nonsterile orthopedic surgical instruments.
The affected units 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. Specific lot numbers are listed in the agency's recall record. Healthcare facilities and users should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,154
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 (13)
- Lot Numbers: 63562125
- 63574359
- 63584041
- 63596754
- 63634173
- 63364063
- 63426473
- 63431723
- 63444632
- 63462281
- 63474170
- 63496895
- 63496896 & 63530398.
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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