Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 1,999 ECT Internal Fracture Fixation Drills 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 1,999 units of the ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, 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 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. The affected units are identified by specific lot numbers, including 63610789, 63610790, 63333727, and others listed in the official recall documentation.
Healthcare providers and facilities should stop using the affected instruments and contact Zimmer Biomet for further instructions on the recall process. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,999
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: 63610789
- 63610790
- 63333727
- 63340530
- 63364066
- 63364067
- 63384623
- 63398757
- 63431747
- 63444664
- 63444666
- 63444667
- 63444668
- 63462334
- 63462340
- 63474387
- 63485135
- 63485138
- 63485141
- 63497203
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.
See all 60 products in this recall →Related recalls
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