Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris
Zimmer Biomet is recalling 2.0mm 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 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,708 units of 2.0mm Ball Nose Guide Wires (Item No. 281017006). 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 units were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, and others.
Healthcare providers and facilities should stop using the affected guide wires and contact Zimmer Biomet for further instructions. Patients who have had these devices implanted should consult their healthcare provider for guidance.
The recalled product
- Product
- 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,708
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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