The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0062-2013·Announced 2012-10-24

Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging Cartons

Zimmer Inc. is removing CPT hip stems from the market because they were packaged in incorrect cartons and distributed domestically and internationally.

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 a Class II recall involving a packaging error (incorrect cartons) rather than a defect in the device itself or a biological hazard. Per the rubric, minor labeling or packaging issues without reported injuries or illnesses fall under Moderate severity.

Plain-English summary

Zimmer Inc. is initiating a removal of the CPT Modular Stem, CPT Stem Petite, and CPT Femoral Stem 12/14 Neck Taper Extended Offset. These devices are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. The recall involves item 00-8114-001-10, specifically lots 61947699 and 61952551, with a total quantity of 59 units across both lots.

The reason for this removal is that the devices were packaged in incorrect cartons. Zimmer Inc. received five complaints regarding this packaging issue. The affected devices were distributed worldwide, including nationwide in the United States (specifically noting Indiana and Oklahoma) and in Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, the UK, the Russian Federation, Slovakia, and Brazil.

Consumers and healthcare providers should verify the item numbers and lot numbers of any CPT hip stems in their possession against the recall details. If the devices match the recalled items, they should contact Zimmer Inc. for further instructions on removal or replacement.

The recalled product

Product
CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
59

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 (2)

  • Item 00-8114-001-10
  • lots 61947699 and 61952551

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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