Zimmer Kopf Adapter S Sterile Recalled for Label Discrepancies
Zimmer Inc. is correcting patient labels for Kopf Adapter S Sterile products manufactured before March 2010 due to reference and lot number discrepancies.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a labeling discrepancy where the source text explicitly states the information printed on the product label is correct, fitting the 'packaging-only problems' or 'documentation issues' criteria for a Low severity score.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of Kopf Adapter S Sterile, Rx products. This action affects units manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland.
The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels. Specifically, the reference and lot numbers on the labels did not match. The source text notes that the information printed on the product label is correct.
The affected products were distributed nationwide. Consumers and healthcare providers should verify the reference and lot numbers on their devices against the provided list to determine if they are affected.
The recalled product
- Product
- Kopf Adapter S Sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 2,011
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: 01.00185.145
- 146
- 147
- 148 2329720
- 2345868
- 2351558
- 2357964
- 2357985
- 2363710
- 2365318
- 2390727
- 2401986
- 2404475
- 2420196
- 2424824
- 2428509
- 2449961
- 2469199
- 2476706
- 2476708
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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