NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

Recall Insight

This FDA Devices action (record #Z-0468-2023) was formally reported on December 21, 2022, with the manufacturer initiating the action on December 6, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 2460 units are affected.

The documented reason for this recall is: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial co… Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.