FDA recall Z-1039-2025

Zimmer, Inc. · Class II · device

Product

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10

Reason for recall

It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.

Distribution

Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO, NE, NJ, PA, TN and the countries of CHINA, INDIA, KOREA, MALAYSIA, NETHERLANDS, SINGAPORE, TAIWAN.

Key facts

Status: Ongoing
Initiation date: 2025-01-06
Report date: 2025-02-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2025