Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
Zimmer Biomet is recalling 4,713 Spinal Rod Cutters because they may fracture during use. The devices were distributed domestically and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (fracture during use) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,713 units of the Spinal Rod Cutter (Item number 00392500200). The recall was initiated because the device has the potential for fracture during use. The product is a nonsterile pin cutter intended for cutting orthopedic rods and pins during orthopedic surgeries.
The affected devices were distributed domestically nationwide and to foreign locations including Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile. The recall covers all lots of the product.
Healthcare providers and facilities should stop using the affected Spinal Rod Cutters and contact Zimmer Biomet for instructions on returning the devices. Patients who have had surgery using these instruments should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 4,713
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
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