Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits 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 and involves a structural defect (instrument fracture) in a surgical device, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Zimmer Biomet, Inc. is recalling 62 units of Straight Shank Drill Bits 4.0 mm Diameter (Item Number/EDI 00231804006). 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 affected lot numbers are 63457688, 63474136, and 63524451.
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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should stop using the affected drill bits immediately. Zimmer Biomet is responsible for managing the recall and will contact customers to arrange for the return or replacement of the affected units.
The recalled product
- Product
- Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 62
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 (2)
- Lot Numbers: 63457688
- 63474136 & 63524451
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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