Zimmer Recalls CPT Modular Hip Stems Due to Packaging Errors
Zimmer Inc. is removing CPT Modular Hip Stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
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 identifies the issue as a packaging error 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 (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05), and CPT Femoral Stem 12/14 Neck Taper Extended Offset (item 00-8114-001-10). These devices are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. The recall affects 59 units from Lot 61947708.
The removal is being conducted because the devices were packaged in incorrect cartons and distributed both internationally and domestically. Zimmer received five complaints regarding this specific packaging issue. The distribution pattern includes the United States (nationwide, including Indiana and Oklahoma) and the countries of 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 Modular Stems in their possession against the details provided in this notice. If the devices match the recalled items, they should contact Zimmer Inc. for further instructions on removal or replacement.
The recalled product
- Product
- CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
- Manufacturer
- Zimmer, Inc.
- 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 (1)
- Lot 61947708
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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