Zimmer Recalls Dynesys Pedicle Screws Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Dynesys Top-Loading System Cannulated Pedicle + Set Screws manufactured before March 2010 due to 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 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 product label information is stated to be correct, fitting the rubric for documentation or packaging-only problems.
Plain-English summary
Zimmer Inc. is initiating a correction for Dynesys Top-Loading System Cannulated Pedicle + Set Screws. The affected units were manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 1,406 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. Specifically, the reference and lot numbers on the patient labels did not match the product labels. The source text notes that the information printed on the product label is correct.
Healthcare providers and patients should verify the reference and lot numbers on the patient labels against the product labels for these specific units. The recall is limited to the labeling correction for the identified units.
The recalled product
- Product
- Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 1,406
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: 01.03915.245
- 01.03916.055
- 01.03916.435
- 01.03916.440
- 01.03916.445
- 01.03916.450
- 01.03916.455
- 01.03917.235
- 01.03917.245
- 01.03917.250
- 01.03917.255
- 01.03918.040
- 01.03918.045
- 01.03918.055
- 01.03955.235
- 01.03955.245
- 01.03955.255
- 01.03956.035
- 01.03956.435
- 01.03956.440
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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