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 cause the instruments to fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a structural defect (instrument fracture) in a surgical tool, which poses a significant risk of injury to patients during procedures.
Plain-English summary
Zimmer Biomet, Inc. is recalling 37 units of ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length (Item Number/EDI 00241002100). These nonsterile 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 drill bits and screw taps. This anomaly may be on or below the surface and can increase the risk of instrument fracture. The affected lot numbers are 63545295, 63634139, 63634141, and 63530410.
Healthcare facilities and distributors should stop using these instruments and contact Zimmer Biomet for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 37
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 (3)
- Lot Numbers: 63545295
- 63634139
- 63634141 & 63530410.
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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