Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills
Zimmer Biomet is recalling 412 ECT Internal Fracture Fixation Quick-Connect 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 412 units of ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length (Item Number/EDI 00241002500, 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 is due to an anomaly in the raw material used to manufacture the drill bits and screw taps. 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 the affected instruments and contact Zimmer Biomet for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 412
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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