The Recall Desk
HighFDA (Devices)·Z-1039-2025·Announced 2025-02-05

Knee Implant Component Recalled for Incorrect Metal Post Assembly

Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy knee implant components because the metal support post was assembled incorrectly in some units. The defective assembly could compromise implant function.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with a documented structural assembly defect affecting a critical orthopedic implant component. While no injuries or illnesses have been reported, the defective assembly of the metal support post poses a risk-of-harm to patients if the implant fails.

Plain-English summary

Zimmer, Inc. is recalling 155 units of the NexGen LCCK Legacy Articular Surface with Locking Screw, specifically Height 10 mm units (Item Number 00-5994-032-10). This product is an orthopedic implant component used in knee replacement surgeries.

The recall was initiated after internal identification of manufacturing defects where the metal support post within the polyethylene articular surface was assembled incorrectly. Three units were identified with this assembly defect within the recalled scope.

The affected units have been distributed worldwide, with specific distribution within the United States in California, Florida, Georgia, Kansas, Missouri, Nebraska, New Jersey, Pennsylvania, and Tennessee. International distribution includes China, India, Korea, Malaysia, Netherlands, Singapore, and Taiwan. Affected lot numbers are 66782843, 66782840, and 66873137.

Patients who received this implant should contact their healthcare provider to discuss whether their implant may be affected. Healthcare providers should verify lot numbers and discontinue use of affected lots. Zimmer, Inc. urges customers to report any adverse events to the FDA.

The recalled product

Product
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
  • assembly-defect
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 00889024635746
  • Lot Numbers:66782843 66782840 66873137

Distribution

Distributed nationwide across the United States.

Related recalls

Same category