Zimmer Biomet Recalls Herbert Cannulated Bone Screw System Drills
Zimmer Biomet is recalling 18 units of Herbert Cannulated Bone Screw System drills due to raw material anomalies that may increase the risk of instrument fracture.
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, which aligns with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 18 units of the Herbert Cannulated Bone Screw System, specifically the Cannulated Main Drill 3.1 mm Diameter (Item Number/EDI 00115501500, Nonsterile). The recall affects lot numbers 63561678, 63444450, and 63475217.
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 during use.
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 providers and facilities should stop using the affected units and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 18
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 (2)
- Lot Numbers: 63561678
- 63444450 & 63475217.
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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