Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic surgical drills and screw taps because raw material anomalies may cause the instruments to fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical devices with potential for harm but no confirmed adverse events.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,037 units of the Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length (Item Number/EDI 00249007543). 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 drill bits and screw taps, 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 numbers are 63541085, 63565537, 63586553, 63586554, 63635381, 63635382, 63660536, 63329874, 63329875, 63343934, 63343935, 63361695, 63370747, 63388956, 63399691, 63399692, 63413799, 63413801, 63413803, 63413804, and 63499022.
Healthcare facilities and users should stop using the affected instruments immediately and contact Zimmer Biomet for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2,037
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 (20)
- Lot Numbers: 63541085
- 63565537
- 63586553
- 63586554
- 63635381
- 63635382
- 63660536
- 63329874
- 63329875
- 63343934
- 63343935
- 63361695
- 63370747
- 63388956
- 63399691
- 63399692
- 63413799
- 63413801
- 63413803
- 63413804 & 63499022.
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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