Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 198 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to 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, fitting the High severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Zimmer Biomet, Inc. is recalling 198 units of ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length (Item Number/EDI 00241002600, 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 the drill bits 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 63289918, 63296044, 63451593, 63457958, 63462351, 63469945, 63479047, and 63518080.
Healthcare facilities and distributors should stop using these instruments and contact Zimmer Biomet for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 198
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 (7)
- Lot Numbers: 63289918
- 63296044
- 63451593
- 63457958
- 63462351
- 63469945
- 63479047 & 63518080.
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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