The Recall Desk
ModerateFDA (Devices)·Z-1253-2014·Announced 2014-03-26

Zimmer Recalls Natural-Knee/Apollo Knee Implants Due to Discoloration

Zimmer, Inc. is recalling 3,638 Natural-Knee/Apollo knee implants because a component was discolored due to premature oxidation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the defect is a cosmetic/quality issue (discoloration) rather than a structural failure.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of Natural-Knee/Apollo knee implants (Item Numbers 620001100, 620001101, and 620001102). The recall covers sizes 0, 1, and 2 of the M/B PAT Natural-Knee line. These devices were distributed nationwide in the United States and in several international countries, including Canada, Australia, India, and various European nations.

The recall was initiated after a complaint was received regarding a discolored All Poly Tibia component. Root cause analysis determined that the discoloration was the result of free radical oxidation. This oxidation process was advanced prematurely because the machined component was stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the return or replacement of these specific units.

The recalled product

Product
Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
3,638

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 (1)

  • Item Number 620001100 620001101 620001102

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

Part of a larger recall action

This product is one of 15 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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