Zimmer Biomet Recalls Orthopedic Drill Pilot Tips Due to Fracture Risk
Zimmer Biomet is recalling 27 nonsterile orthopedic drill pilot tips 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, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Zimmer Biomet, Inc. is recalling 27 units of the M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter (Item Number/EDI 00225503337). These are nonsterile orthopedic surgical instruments. The recall is classified as Class II by the U.S. Food and Drug Administration.
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. The affected lot number is 63505310.
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 facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 27
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: 63505310
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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