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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Zimmer NexGen LCCK Articular Surfaces Recalled for Assembly Defect

Agency Publication Date: January 28, 2025
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Summary

Zimmer, Inc. is recalling 155 units of NexGen LCCK Legacy Articular Surfaces after identifying that the metal support post inside the plastic surface was assembled incorrectly for some units. These medical devices are used in knee replacement surgeries and were sold to hospitals and surgical centers. While only three units were confirmed to have the defect, all units within the specified lot ranges are being recalled as a precaution. No injuries or incidents have been reported.

Risk

An incorrectly assembled metal support post can cause the knee implant to fail or function improperly. This defect could lead to patient discomfort, loss of mobility, or the need for additional surgery to replace or correct the device.

What You Should Do

  1. This recall involves Zimmer NexGen LCCK Legacy Articular Surfaces with Locking Screws, specifically the Striped Purple model (14 mm height) and Striped Yellow model (10 mm height).
  2. Identifying identifiers include Item Numbers 00-5994-022-14 and 00-5994-032-10. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: NexGen LCCK Legacy Articular Surface with Locking Screw (Height 14 mm)
Variants: Striped Purple/C,D, 14 mm Height
Model / REF:
00-5994-022-14
Lot Numbers:
66602503
66520665
66881918
66949906
UDI:
00889024635647

Recall #: Z-1038-2025

Product: NexGen LCCK Legacy Articular Surface with Locking Screw (Height 10 mm)
Variants: Striped Yellow/E,F, 10 mm Height
Model / REF:
00-5994-032-10
Lot Numbers:
66782843
66782840
66873137
UDI:
00889024635746

Recall #: Z-1039-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96090
Status: Active
Manufacturer: Zimmer, Inc.
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 2 products (155 units)
Distributed To: California, Florida, Georgia, Kansas, Missouri, Nebraska, New Jersey, Pennsylvania, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.