Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 3, 2012
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 Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeri
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the compl…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra Limited recalled The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units an… - a moderate-severity action.
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units an… was recalled by Integra Limited in October 3, 2012. Reason: An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were pa…. Check the official notice for the remedy. Verify recall #Z-2458-2012 with the FDA Devices before acting.
The recall
Integra Limited issued this moderate-severity FDA Devices recall-An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were pa….
- Moderate
- severity level
- Class II
- classification
- October 3, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2458-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2458-2012) was formally reported on October 3, 2012, with the manufacturer initiating the action on July 27, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra Limited is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records list the affected scope as 18 from Lot 093984 for Right Gel Pads.
The documented reason for this recall is: An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient in… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18 from Lot 093984 for Right Gel Pads
Related Recalls
6
3 from same agency
Product description
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 Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: 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. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.
Reason for recall
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. 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, onl
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2458-2012 |
| Date reported | October 3, 2012 |
| Date initiated | July 27, 2012 |
| Recalling firm | Integra Limited |
| Firm location | Plainsboro, NJ |
| Affected scope | 18 from Lot 093984 for Right Gel Pads |
| Distribution | Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2458-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: 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. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.. Recalled by Integra Limited. Units affected: 18 from Lot 093984 for Right Gel Pads.
Why was this product recalled? ▼
An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. 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, onl
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2458-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2458-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 3, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.