Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris
Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a risk of harm (bacterial endotoxin and debris) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,468 units of the GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire (Item No. 809222028). These instruments are used to facilitate the implantation of orthopedic medical devices.
The recall is being conducted because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The affected products were distributed nationwide in the United States and in numerous international countries, including Argentina, Australia, Brazil, Canada, and others.
Healthcare providers and consumers should check their inventory for the specific lot numbers and UDI codes listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or a designated facility in accordance with the recall instructions.
The recalled product
- Product
- GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,468
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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