Zimmer Biomet Recalls M/DN Intramedullary Fixation Femoral Drill Bits
Zimmer Biomet is recalling 25 units of M/DN Intramedullary Fixation Femoral Drills 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, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 25 units of M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter (Item Number/EDI 00225503137, Lot Number 63562128). These nonsterile 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 these 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 source text does not report any specific injuries or illnesses associated with this defect.
Healthcare providers and facilities that have received these specific drill bits should stop using them and contact Zimmer Biomet for instructions on return or replacement. Consumers should not use these medical devices, as they are intended for professional surgical use.
The recalled product
- Product
- M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 25
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 (1)
- Lot Number: 63562128
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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