Zimmer Recalls Dynesys Revision Set Screws Due to Label Discrepancies
Zimmer Inc. is correcting patient labels for Dynesys Revision set screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
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 source text indicates the issue is a labeling discrepancy where 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 Dynesys Revision + set screws. The affected products were manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 1,575 units distributed nationwide.
The correction is being made 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.
Consumers and healthcare providers should verify the reference and lot numbers of the devices against the provided lists. The specific reference numbers include 01.03716.035, 01.03716.040, 01.03716.045, 01.03716.050, 01.03716.435, 01.03716.440, 01.03716.445, 01.03716.450, 01.03716.455, and 01.03717.250. The affected lot numbers are 2368864, 2344115, 2367073, 2396142, 2334238, 2444021, 2377110, 2305486, 2377111, 2323497, 2389720, 2403550, 2433036, 2444022, 2298967, 2305536, 2348795, 2358159, 2368866, 2368867, 2389721, 2394352, 2449099, 2368870, 2441343, 2367060, 2367062, 2373095, and 2373097.
The recalled product
- Product
- Dynesys¿ Revision + set screw
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,575
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: 01.03716.035
- 01.03716.040
- 01.03716.045
- 01.03716.050
- 01.03716.435
- 01.03716.440
- 01.03716.445
- 01.03716.450
- 01.03716.455 and 01.03717.250 Lot: 2368864
- 2344115
- 2367073
- 2396142
- 2334238
- 2444021
- 2377110
- 2305486
- 2377111
- 2323497
- 2389720
- 2403550
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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