PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 5, 2025 Initiated: January 6, 2025 #Z-1039-2025

Product Description

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
155 units
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.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10. Recalled by Zimmer, Inc.. Units affected: 155 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1039-2025.