Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 1,255 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that 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, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,255 units of ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. These orthopedic surgical instruments were distributed nationwide in the USA 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 being conducted because various trauma and extremity instruments, including these drill bits and screw taps, were 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 lot numbers are 63556702, 63593924, 63593925, 63616888, 63340538, 63340539, 63358202, 63358203, 63372868, 63398777, 63478700, 63479007, 63479008, 63479009, 63517947, and 63524439.
Healthcare providers and facilities should stop using these instruments and contact Zimmer Biomet for instructions on returning or disposing of the affected units.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,255
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 (15)
- Lot Numbers: 63556702
- 63593924
- 63593925
- 63616888
- 63340538
- 63340539
- 63358202
- 63358203
- 63372868
- 63398777
- 63478700
- 63479007
- 63479008
- 63479009
- 63517947 & 63524439.
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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