Zimmer Biomet Recalls Orthopedic Surgical Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 62 units of the Natural Nail System Calibrated Drill Short 4.9 mm 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, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 62 units of the Zimmer Natural Nail System Calibrated Drill Short 4.9 mm (Item Number/EDI 00249006449, Nonsterile). 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 affected lot number is 63606634.
The recall was initiated because various trauma and extremity instruments, including drill bits and screw taps, 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 source text does not report any specific injuries or illnesses associated with this recall.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for further instructions. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, 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 (1)
- Lot Number: 63606634
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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