Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
Zimmer Biomet is recalling 1,091 nonsterile orthopedic surgical drills and screw taps because raw material anomalies may cause instrument fracture.
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 severity (structural vehicle defect or significant injury/property-damage reports, or high-risk medical device defects).
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,091 units of the Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter (Item Number/EDI 00236017520). 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 during use. The affected lot numbers are 63599481, 63461425, 63469758, 63475225, and 63481881.
Healthcare facilities and distributors should stop using these instruments and contact Zimmer Biomet for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,091
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 (4)
- Lot Numbers: 63599481
- 63461425
- 63469758
- 63475225 & 63481881.
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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