Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.
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, which typically corresponds to a High severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is a potential sterile packaging failure.
Plain-English summary
Zimmer Biomet, Inc. is recalling ZMS Intramedullary Fixation Smooth Guide Wires (3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00) because of a potential failure of the sterile packaging seal. The recall involves 19,483 units distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad.
The affected products are identified by the following lot numbers: 63662549, 63668704, 63696974, 63709171, 63721377, 63731176, 63764550, 63771164, 63781920, 63803595, 63812302, 63817719, and 63826242. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should check their inventory for the specific item number and lot numbers listed above. If the affected 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 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
- 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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