Recall Z-1038-2025— Zimmer, Inc.

Name: FDA recall Z-1038-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-06

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2025-01-06. It names one FDA 510(k) clearance: K960279. Product: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14. Reason: 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..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-01-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K960279 — NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACESZimmer, Inc.·cleared 1996-04-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.