Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument 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 and involves a structural defect (instrument fracture) in a surgical device, which aligns with the rubric criteria for 'Severe' (structural vehicle defect or significant injury/property-damage reports, or high-risk structural failures in medical devices).
Plain-English summary
Zimmer Biomet, Inc. is recalling 15 units of Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length (Item Number/EDI 00480719545). 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 affected lot numbers are 63570251, 63570254, 63593917, and 63462292.
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 FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities that have received these specific drill bits should stop using them immediately 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 about the integrity of the implants or instruments used.
The recalled product
- Product
- Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 15
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 (3)
- Lot Numbers: 63570251
- 63570254
- 63593917 & 63462292.
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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