Zimmer Recalls Wagner Cone Prostheses Due to Label Discrepancies
Zimmer Inc. is correcting patient labels for Wagner cone prostheses 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 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 classified as FDA Class II but involves a labeling discrepancy where the source states the product label information is correct, fitting the criteria for documentation or packaging-only problems.
Plain-English summary
Zimmer Inc. is initiating a correction for Wagner cone prostheses that are uncemented, sterile, and prescription-only. The affected units were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 56 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 complaints noted differences in the reference and lot numbers. The source text indicates that while the information printed on the product label is correct, the discrepancy exists in the labeling documentation.
Consumers and healthcare providers should verify the reference and lot numbers of the affected prostheses against the provided lists. The specific reference numbers involved are 01.00561.214, 01.00561.215, 01.00561.222, 01.00561.313, 01.00561.314, 01.00561.316, 01.00561.317, 01.00561.318, 01.00561.319, and 01.00561.321. The associated lot numbers include 2323157, 2411401, 2505266, 2352457, 2323311, 2381296, 2446509, 2336139, 2451855, 2397244, 2451874, 2459988, 2517770, 2528611, 2455390, 2336084, and 2413210.
The recalled product
- Product
- Wagner cone Prosthesis, uncemented, sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 56
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: 01.00561.214
- 01.00561.215
- 01.00561.222
- 01.00561.313
- 01.00561.314
- 01.00561.316
- 01.00561.317
- 01.00561.318
- 01.00561.319
- and 01.00561.321 Lot:2323157
- 2411401
- 2505266
- 2352457
- 2323311
- 2381296
- 2446509
- 2336139
- 2451855
- 2397244
- 2451874
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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