Zimmer Recalls Dynesys HA Pedicle Screws Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.
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 explicitly states the product label information is correct and the issue is a labeling discrepancy, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
Zimmer Inc. is initiating a correction for Dynesys HA Pedicle + set screw products manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 1,247 units distributed nationwide.
The action was taken after the company received four complaints regarding discrepancies 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 exists in the patient labels.
Healthcare providers and patients should verify the reference and lot numbers of the implanted devices against the product labels to ensure accurate documentation. Zimmer Inc. is the recalling firm responsible for this correction.
The recalled product
- Product
- Dynesys¿ HA Pedicle + set screw
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,247
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: 01.03756.040
- 01.03756.050
- 01.03756.440
- 01.03756.445
- 01.03756.450
- 01.03756.455
- 01.03757.235
- 01.03757.240
- 01.03757.245
- 01.03757.250
- 01.03757.255
- 01.03758.040
- 01.03758.050 and 01.03758.055 Lot: 2399360
- 2502246
- 2519160
- 2323382
- 2399361
- 2459377
- 2500751
- 2383797
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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