Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills
Zimmer Biomet is recalling 4,423 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
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 and involves a structural defect (instrument fracture) in a surgical device, which meets the criteria for a Severe rating due to the potential for significant injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,423 units of the ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. This orthopedic surgical instrument is being recalled because it was manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
The affected products 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 covers specific lot numbers, including 63545283, 63578152, and 63578153, among others.
Healthcare facilities and distributors should stop using the affected drill bits and contact Zimmer Biomet for instructions on returning the products. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4,423
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: 63545283
- 63578152
- 63578153
- 63584052
- 63358182
- 63358184
- 63364075
- 63384616
- 63384617
- 63384618
- 63398734
- 63398735
- 63415287
- 63415288
- 63426487
- 63426488
- 63431725
- 63431730
- 63438313
- 63438315
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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