Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 356 ECT Internal Fracture Fixation Drills because a raw material anomaly 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.
Plain-English summary
Zimmer Biomet, Inc. is recalling 356 units of the ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. This orthopedic surgical instrument was 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 recall is due to a raw material anomaly in the manufacturing process. The anomaly may be on or below the surface of the instrument and can increase the risk of instrument fracture. The affected lot numbers are 63556745, 63630284, 63641610, 63358212, 63364073, 63457891, 63479015, 63479016, and 63524446.
Healthcare facilities and users should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 356
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 (8)
- Lot Numbers: 63556745
- 63630284
- 63641610
- 63358212
- 63364073
- 63457891
- 63479015
- 63479016 & 63524446.
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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