Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging
Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
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 hazard is limited to incorrect packaging cartons with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
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 is being conducted because the devices were packaged in incorrect cartons and distributed both internationally and domestically. Zimmer received five complaints regarding this packaging issue.
The affected products include Item No. 00-8011-001-00, Item No. 00-8011-000-05, and Item No. 00-8114-001-10. The distribution pattern includes the United States (nationwide, including Indiana and Oklahoma) and several international countries, including Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, the UK, the Russian Federation, Slovakia, and Brazil. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 20
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 62017554
Distribution
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.
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