Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills
Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in medical devices that pose a risk of fracture, are categorized as Severe (Score 4).
Plain-English summary
Zimmer Biomet, Inc. is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. The affected orthopedic surgical instruments 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 specific lot numbers involved are 63584061 and 63634136.
The recall was initiated because various trauma and extremity instruments, including these 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 providers and facilities that have received these specific units should stop using them immediately and contact Zimmer Biomet for instructions on return or disposal. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4
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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