Zimmer Recalls CoCr Head Sterile Orthopedic Implants Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for CoCr Head sterile implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
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 and involves a labeling discrepancy where the source text explicitly states the product label information is correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Inc. is initiating a correction for patient labels on CoCr Head, sterile, Rx products. This action involves 1,000 units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The products were distributed nationwide.
The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy was identified in the patient labels.
Healthcare providers and patients should verify the reference and lot numbers of the affected implants against the provided lists. The specific REF numbers and lot numbers are detailed in the official recall documentation.
The recalled product
- Product
- CoCr Head, sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,000
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 (20)
- REF Numbers: 01.01012.384
- 01.01012.385
- 01.01012.386
- 01.01012.387
- and 01.01012.388 Lot2369409
- 2435773
- 2448280
- 2480485
- 2397348
- 2402739
- 2412633
- 2420719
- 2481695
- 2520521
- 2333576
- 2354292
- 2369416
- 2398778
- 2412631
- 2447614
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 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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