Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.
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 is classified as FDA Class II. Per the rubric, a Class II recall involving a structural defect (instrument fracture) that poses a significant risk of injury is rated as Severe (4).
Plain-English summary
Zimmer Biomet, Inc. is recalling 228 units of nonsterile orthopedic surgical instruments, specifically Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length (Item Number/EDI 00480513032). The recall covers various trauma and extremity instruments, including drill bits and screw taps.
The recall was initiated because the instruments were manufactured from raw material with an anomaly. This anomaly may be located on or below the surface of the instrument and can increase the risk of the instrument fracturing during use. The affected lot numbers are 63550421, 63570257, 63634090, 63306459, 63377487, and 63492354.
The 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 specific instruments and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 228
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 (5)
- Lot Numbers: 63550421
- 63570257
- 63634090
- 63306459
- 63377487 & 63492354
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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