Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
Zimmer Biomet is recalling 2 units of Long Drill 1/4 inch orthopedic surgical instruments due to raw material anomalies that may increase the risk of instrument fracture.
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 2 units of Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length orthopedic surgical instruments, Item Number/EDI 00129100400, Lot Number 63562128. The products are nonsterile and 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.
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 during use.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2
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: 63562128
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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