Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterile packaging failure, which poses a risk of infection (a high-risk hazard) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of the M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only (Item Number: 00-2255-025-00). The recall is due to a potential failure of the sterile packaging seal. The affected lots are 63733049, 63738623, 63748399, 63753770, 63758430, 63849380, 77006555, 77006556, and 77006557.
The products were distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed. Patients who have already received these devices should contact their healthcare provider for further instructions.
The recalled product
- Product
- M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19,483
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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