Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 705 nonsterile orthopedic drill bits and screw taps because raw material anomalies may cause 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.
Plain-English summary
Zimmer Biomet, Inc. is recalling 705 units of nonsterile orthopedic surgical instruments, specifically Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length (Item Number/EDI 0048060851) and various screw taps. The recall affects specific lot numbers: 63570260, 63574325, 63584027, 63451638, 63451640, 63457758, 63457921, 63478937, 63478942, 63478945, 63484951, 63492357, 63496853, and 63510771.
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 the instrument fracturing during use. The FDA has classified this as a Class II recall.
The affected products 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. Healthcare facilities and distributors should stop using these instruments and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 705
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 (13)
- Lot Numbers: 63570260
- 63574325
- 63584027
- 63451638
- 63451640
- 63457758
- 63457921
- 63478937
- 63478942
- 63478945
- 63484951
- 63492357
- 63496853 & 63510771.
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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