Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 224 sterile M/DN Intramedullary Fixation Distal 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 is classified as FDA Class II, and the hazard involves a risk of instrument fracture during surgery, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 224 units of the M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip (Item Number/EDI 47225503332). These sterile 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. The anomaly may be on or below the surface and can increase the risk of instrument fracture. The affected lot numbers are 63616770, 63616771, 63616772, 63413732, 63413734, 63413737, 63443859, 63443861, 63443836, 63469287, 63469288, 63469289, 63474646, 63474647, 63474648, 63511483, 63529994, 63529995, 63529996, and 63530003.
Healthcare providers and facilities should stop using these specific instruments and contact Zimmer Biomet for instructions on return or replacement. Patients who have had surgery using these instruments should contact their healthcare provider if they have concerns.
The recalled product
- Product
- M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 224
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 (19)
- Lot Numbers: 63616770
- 63616771
- 63616772
- 63413732
- 63413734
- 63413737
- 63443859
- 63443861
- 63443836
- 63469287
- 63469288
- 63469289
- 63474646
- 63474647
- 63474648
- 63511483
- 63529994
- 63529995
- 63529996 & 63530003
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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