Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error
Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.
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 2/5 (Moderate).
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, but the source explicitly states that no patient injuries were reported and a physician concluded there is no potential harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra Limited is recalling specific lots of Mayfield Horseshoe Gel Pads used in neurosurgery. The recall was initiated after an investigation of customer complaints revealed that for two product lots, Left Horseshoe Gel Pads were packaged as Right Horseshoe Gel Pads, and vice versa. The affected units are from Lot 093984 of part number 440C1011 for Right Gel Pads, with 18 units identified in this specific lot.
The devices are used in conjunction with Mayfield Base Units and Swivel Adaptors to provide cranial stability during craniotomies and spinal procedures. The distribution was worldwide, including the US nationwide (specifically AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY) and the countries of Canada and Belgium.
According to the source text, none of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients. Consumers and healthcare facilities should stop using the affected gel pads and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The…
- Manufacturer
- Integra Limited
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 recalled by Integra Limited 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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