Zimmer Recalls Dynesys Universal Spacers Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers 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, but the source text explicitly states that the information printed on the product label is correct and the issue is a labeling discrepancy. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls where the physical product is not defective.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of Dynesys Universal spacer 6-45 products. This action involves 5,069 units that were 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.
Consumers and healthcare providers should verify the reference and lot numbers of the affected products against the provided list to ensure accurate patient records. The specific reference number is 01.03710.645, and the affected lot numbers include 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, and 2469132.
The recalled product
- Product
- Dynesys¿ Universal spacer 6-45
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 5,069
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 Number: 01.03710.645
- Lot 2323776
- 2340853
- 2347195
- 2347196
- 2349405
- 2352968
- 2361598
- 2363757
- 2368549
- 2371803
- 2374584
- 2374695
- 2390243
- 2390244
- 2392322
- 2394946
- 2395677
- 2410170
- 2410171
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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