The Recall Desk
ModerateFDA (Devices)·Z-1254-2014·Announced 2014-03-26

Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration

Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.

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. The hazard is a cosmetic defect (discoloration) resulting from storage conditions, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is recalling 3,638 units of Natural-Knee Congruent Tibial Inserts with Screws. The affected items include specific left and right sizes (SZ1/2 and SZ3/4/5) under item numbers 620005819, 620005909, and 620006916. The 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. Root cause analysis determined that the discoloration resulted from free radical oxidation. This oxidation process was advanced prematurely because the machined components were stored in transparent containers exposed to artificial light for six years prior to inert packaging and sterilization.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any illnesses or injuries associated with the use of these implants. The recall is classified as Class II by the FDA.

The recalled product

Product
Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
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 620005819 620005909 620006916

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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Same hazard · discoloration

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