The Recall Desk
ModerateFDA (Devices)·Z-1250-2014·Announced 2014-03-26

Zimmer Recalls MOST Options Hinged Tibia Inserts Due to Discoloration

Zimmer, Inc. is recalling 3,638 units of MOST Options System hinged tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

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, but the source text describes 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 the MOST Options System, specifically the Hinged Tibia Inserts and Prox Tibia Inserts. The affected item numbers are 502001016, 502004006, 502004009, 502004016, and 502010006. These medical 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 caused by 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 before being placed in inert packaging and sterilized.

This recall is classified as Class II by the FDA. Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions or replacement.

The recalled product

Product
MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM
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 502001016 502004006 502004009 502004016 502010006

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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