Integra LifeSciences Recalls Mayfield Composite Series Base Units
Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes performance issues impacting functionality without reporting specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corporation is recalling specific lots of the MAYFIELD Composite Series Base Unit, Model A3101, and Mayfield Skull Clamps. The recall includes Base Units with Lot Numbers 097547 and 096546. The Swivel Adaptor (A3018) is an integral component of the Base Unit.
The recall was initiated after an investigation of an adverse trend of complaints identified various product performance issues. These issues could impact the functionality of the Base Units and Skull Clamps, which are operating room table accessories intended to support patients during diagnostic examinations or surgical procedures. The firm decided to recall and replace the affected units to prevent additional complaint reports.
A total of 5 base units were distributed nationwide, including to facilities in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. Users should contact the manufacturer for replacement.
The recalled product
- Product
- MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 5
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)
- The recalle product is identified with the Lot Numbers: 097547 and 096546.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corporation 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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