Zimmer Inverse/Reverse Screw System Label Correction
Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems 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: This is a Class II recall involving a labeling discrepancy where the source text explicitly states the product label information is correct, indicating a minor labeling error or documentation issue rather than a direct safety hazard.
Plain-English summary
Zimmer, Inc. is initiating a correction to the patient labels of Zimmer Inverse/Reverse Screw system products. This action affects 45 units distributed nationwide that were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland.
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 lists. The specific reference numbers involved are 01.04223.018, 01.04223.024, 027, 030, 033, 036, and 042, associated with various lot numbers listed in the recall documentation.
The recalled product
- Product
- Zimmer Inverse/Reverse Screw system,
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 45
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: . 01.04223.018
- 01.04223.024
- 027
- 030
- 033
- 036
- 042 Lot 2398030
- 2430525
- 2384923
- 2390913
- 2396961
- 2399397
- 2416652
- 2424581
- 2430509
- 2449770
- 2497224
- 2383780
- 2430522
- 2430523
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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