Zimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips
Zimmer Biomet is recalling 182 M/DN Intramedullary Fixation Distal Drill Pilot Tips due to raw material anomalies that may increase the risk of instrument fracture.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (raw material anomaly) in a surgical instrument that increases the risk of fracture, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' by analogy to critical mechanical failure in a medical device context, warranting a Severe classification.
Plain-English summary
Zimmer Biomet, Inc. is recalling 182 units of M/DN Intramedullary Fixation Distal Drill Pilot Tips, 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. These are orthopedic surgical instruments used for trauma and extremity procedures.
The recall was initiated because the instruments 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 during use. The affected lot numbers are 63574676, 63574677, 63574678, 63424385, 63451742, 63493677, and 63493680.
The products 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. Healthcare providers and facilities should stop using these specific instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 182
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 (6)
- Lot Numbers: 63574676
- 63574677
- 63574678
- 63424385
- 63451742
- 63493677 & 63493680
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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