Device product

Connecting Bolt, Model 14-442093

Z-2875-2018

June 18, 2018

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 80543
Status: Terminated
Classification: Class II
Quantity: 247 units
Official record key: device-enforcement:Z-2875-2018

Official wording

Reason: Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.

Code information: ...

Distribution pattern: AR, AZ, CA, FL, GA, IN, KY, LA, MA, MI, MN, MO, MT, NJ, NY, OH, SC, TX, UT & WI

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.