Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues
Zimmer Biomet is recalling Ball Nose 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 contamination hazard (bacterial endotoxin and debris) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling Ball Nose Guide Wires (80cm and 100cm) used to facilitate the implantation of orthopedic medical devices. The recall is due to a cleaning issue that resulted in elevated levels of bacterial endotoxin and residual debris remaining on the devices.
The affected products include Item Nos. 281001080 and 281001100. A total of 1,729 units were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, and others. The source text lists specific lot numbers and UDI codes associated with the recalled units.
Healthcare providers and consumers should stop using the affected Ball Nose Guide Wires immediately. Zimmer Biomet is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,729
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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