Recall Z-2875-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-06-18, terminated 2020-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Connecting Bolt, Model 14-442093. 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-18
- Terminated
- 2020-03-26
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.