The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0301-2018·Announced 2018-01-10

Zimmer Biomet Recalls CER OPTION TYPE 1 TPR SLEVE -6 Due to Labeling Error

Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.

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: This is classified as a moderate severity recall because it involves a minor labeling error where the outer box and product are correctly identified, and no adverse health consequences or injuries are reported in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices, model # 650-1064, lot number 854540. The recall was initiated because the patient label inside the product box may have been incorrectly labeled.

The outer box label and the actual product are correctly identified, but the internal patient label could be incorrect. This device was distributed nationwide in the US and internationally in Argentina, the Netherlands, and Canada.

Consumers and healthcare providers should verify the product identification against the outer box label and contact Zimmer Biomet for further instructions regarding the internal labeling discrepancy.

The recalled product

Product
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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)

  • Lot Number: 854540

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Zimmer Biomet, 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 10 products in this recall →

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