EXP recalls Stryker Round Fluted Burs due to registration violations
EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs 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. 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 or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling three units of Stryker Round Fluted Bur Soft Touch (2.0mm), sterile, single-use devices. The products are identified by OEM Catalog number 5820-10-120 and were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
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 source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of these devices.
The recalled product
- Product
- Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 3
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 5820-10-120.
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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