EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur
EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a 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, but the source text indicates the hazard is a regulatory compliance failure (lack of registration and quality system) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two units of Medical Device Exchange Round Diamond Bur Extra Coarse, 3.0mm, sterile, single-use devices. The recall was initiated because EXP did not register as a medical device establishment, did not list the devices being recalled, and did not establish its own quality system. Instead, the company relied on its vendors being registered and having their own quality systems.
The affected devices are identified by OEM Catalog number 5820-10-130. The products were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. The recall is classified as Class II by the FDA.
Consumers and healthcare providers who possess these specific devices should stop using them and contact EXP Pharmaceutical Services Corp for further instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
- 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 5820-10-130.
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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