The Recall Desk
HighFDA (Devices)·Z-2875-2018·Announced 2018-08-29

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.

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 (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
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)

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Distribution