Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure
Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System 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 the hazard involves a potential sterile packaging failure for an invasive medical device, which presents a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of the Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter (Item Number: 00-2228-024-00). 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 were distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The specific lot numbers involved in this recall are 63655999, 63715685, 63731170, 63733045, and 63812299.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected guide wires. Patients who have had these devices implanted should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
- Manufacturer
- Zimmer Biomet, Inc.
- 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: 63655999 63715685 63731170 63733045 63812299
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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