Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly
Zimmer Biomet is recalling 3,232 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.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,232 units of ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. The affected 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 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 source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and facilities should stop using the affected drill bits and contact Zimmer Biomet for instructions on return or replacement. The specific lot numbers affected are: 63545287, 63315176, 63315178, 63315180, 63319001, 63333734, 63333736, 63333737, 63333795, 63333799, 63340564, 63340568, 63347076, 63350788, 63358204, 63384635, 63415299, 63415303, 63426466, 63426492, 63457631, 63457779, 63457780, 63457781, 63457949, 63469913, 63469915, 63469917, 63469919, 63474421, 63478996, 63518027, 63518029, and 63518031.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,232
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: 63545287
- 63315176
- 63315178
- 63315180
- 63319001
- 63333734
- 63333736
- 63333737
- 63333795
- 63333799
- 63340564
- 63340568
- 63347076
- 63350788
- 63358204
- 63384635
- 63415299
- 63415303
- 63426466
- 63426492
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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