Class II — Integra Limited
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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 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 betwe… |
| Quantity | 11 from Lot 0938990 |
| 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. |
| Initiated | 2012-07-27 |
| Classified | 2012-09-25 |
| Terminated | 2013-02-20 |
| Recall number | Z-2457-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra Limited (Z-2457-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62711/
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