Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0783-2014·Announced 2014-01-29

Zimmer Segmental Systems Polyethylene Inserts Recalled for Loading Instructions

Zimmer, Inc. is recalling Segmental Systems Polyethylene Inserts to update surgical instructions regarding excessive loading risks.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 procedural update to instructions for use rather than a defect causing reported injuries or hospitalizations, fitting the criteria for a moderate severity precautionary update.

Plain-English summary

Zimmer, Inc. is recalling Zimmer Segmental Systems Polyethylene Inserts, Size B. These medical devices are designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty. The recall involves part number 00-5850-012-95.

The recall was initiated after the evaluation of 13 complaints, representing a 0.4% rate, regarding the hyper-extension of the Zimmer Segmental System. As a result, Zimmer is updating the related surgical technique and instructions for use to provide additional guidance on patient conditions that may place excessive loading on the polyethylene insert.

The affected units were distributed worldwide, including nationwide in the USA and Germany, with further distribution into EU countries. A total of 5,305 distribution events are associated with this recall. No specific instructions for consumers are provided in the source text, but the recall focuses on updating professional surgical instructions.

The recalled product

Product: Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-failure
mis-labeling
Affected units: 5,305

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)

Part numbers 00-5850-012-95

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Zimmer, Inc.

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