Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 2,038 ECT Internal Fracture Fixation Drill Bits 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 (surgical instrument fracture) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,038 units of ECT Internal Fracture Fixation Drill Bits, 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, 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 recall is being conducted 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 affected lot numbers are: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347022, 63347034, 63358186, 63358201, 63372867, 63398739, 63398761, 63398762, 63426475, 63426476, 63426478, 63431754, 63431755, 63457862, 63457863, 63457865, 63457889, 63474135, 63479010, 63479011, 63479013, 63524442, 63524443, and 63524445.
Healthcare facilities and distributors should stop using these specific drill bits and contact Zimmer Biomet for further instructions on the recall process.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2,038
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 (20)
- Lot Numbers: 63556703
- 63566220
- 63593926
- 63593928
- 63593930
- 63630281
- 63340536
- 63340537
- 63347015
- 63347018
- 63347022
- 63347034
- 63358186
- 63358201
- 63372867
- 63398739
- 63398761
- 63398762
- 63426475
- 63426476
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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