Zimmer Recalls CPT Hip System Components Due to Incorrect Packaging
Zimmer is recalling specific CPT Hip System parts because they were packaged in the wrong outer cartons, though the product labels are correct.
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 labeling/packaging error where the product labels are correct, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Zimmer, Inc. is initiating a lot-specific recall of the CPT Hip System, specifically parts 00-8114-002-10 and 00-8011-004-00. These are hip joint metal/polymer semi-constrained cemented prostheses indicated for various hip conditions, including arthritis and fractures.
The recall is due to reports that the products were packaged in the incorrect outer carton. The source text confirms that the product labels and patient labels are correct. The affected units are lot-controlled, with 36 units originally distributed. According to the distribution data, 7 units have been returned, leaving 64 affected units in the field subject to removal. Distribution was worldwide, including the United States and Germany.
Healthcare providers and patients should verify the lot numbers of their devices. Part 00-8114-002-10 is associated with Lot 62424414, and Part 00-8011-004-00 is associated with Lot 62406423. If these specific lots are identified, the devices should be removed from use and returned to the manufacturer.
The recalled product
- Product
- CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 36
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 (3)
- Part 00-8114-002-10
- Lot 62424414 Part 00-8011-004-00
- Lot 62406423
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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