Zimmer Biomet Recalls Intramedullary Fixation Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of ZMS Intramedullary Fixation Smooth Guide Wires (2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00). The recall is due to a potential failure of the sterile packaging seal, which could compromise the sterility of the medical device.
The affected products are distributed in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The specific lot numbers involved are 63715690, 63780127, and 63787482.
Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers. If the recalled products are found, they should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 19,483
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 (1)
- Lot Numbers: 63715690 63780127 63787482
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Zimmer Biomet, 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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