EXP Pharmaceutical Services Recalls Mayfield Disposable Skull Pins
EXP Pharmaceutical Services Corp is recalling Mayfield Disposable Skull Pins because the company failed to register as a medical device establishment or maintain its own quality system.
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. The hazard is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported illness, fitting the Moderate severity criteria for minor or procedural issues.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of Mayfield Disposable Skull Pins (OEM Catalog number A1072). These neurosurgical skull clamp components are sterile, single-use pouches repackaged by EXP from the original manufacturer, Integra.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems, which does not meet FDA requirements for the repackager.
The affected products were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare facilities should stop using these products and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 2
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)
- OEM Catalog number A1072.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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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