Zimmer Biomet Recalls Connecting Bolts Due to Material Error
Zimmer Biomet is recalling 247 connecting bolts made from incorrect material, which may decrease fatigue strength and lead to fracture.
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 (potential fracture) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 247 units of the Connecting Bolt, Model 14-442093. The recall was initiated because the product was manufactured from the incorrect material.
The use of the incorrect material presents a potential decrease in the fatigue strength of the connecting bolt, which can lead to fracture. The affected units were distributed to facilities in Arkansas, Arizona, California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New York, Ohio, South Carolina, Texas, Utah, and Wisconsin.
Healthcare professionals and patients who have received this product should contact Zimmer Biomet for further instructions on how to proceed.
The recalled product
- Product
- Connecting Bolt, Model 14-442093
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 247
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)
- ...
Distribution
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