Z-2875-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

FDA device recall Z-2875-2018 was initiated by Zimmer Biomet, Inc. on Jun 18, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Mar 26, 2020). Affected quantity: 247 units.

Recall Details

Product Type
Devices
Report Date
Aug 29, 2018
Initiation Date
Jun 18, 2018
Termination Date
Mar 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
247 units

Product Description

Connecting Bolt, Model 14-442093

Reason for Recall

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.

Distribution Pattern

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

Code Information

...

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2875-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.