Zimmer Biomet Recalls Orthopedic Surgical Drill Bits and Screw Taps
Zimmer Biomet is recalling specific orthopedic surgical instruments due to a raw material anomaly that 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 medical device, which aligns with the rubric criteria for a Severe rating (Score 4) due to the potential for significant injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,055 units of the Zimmer Natural Nail System Calibrated Drill Long 4.3mm (Item Number/EDI 00249004443, Nonsterile). These orthopedic surgical instruments, which include drill bits and screw taps, 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 units are identified by Lot Numbers 63584061 and 63634136.
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 as a Class II recall, 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 facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement. Consumers are not directly affected as these are professional medical devices used in surgical settings.
The recalled product
- Product
- Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,055
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 (1)
- Lot Numbers: 63584061 & 63634136
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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