EXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices
EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.
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 source text identifies a regulatory compliance failure (lack of establishment registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling six units of Stryker Round Fluted Bur Aggressive (4.0mm) devices. The devices are sterile, single-use, and packaged in Tyvek/Mylar pouches. The recall is identified by OEM Catalog number 5820-10-240.
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.
The affected devices were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using these devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 6
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 5820-10-240.
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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