EXP Recalls Unregistered Orthopedic Saw Blades Due to Regulatory Non-Compliance
EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 issue is administrative (failure to register/establish quality system) rather than a direct physical defect or reported injury, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling two sterile, single-use orthopedic saw blades (OEM Catalog number 5059-531) manufactured by Linvatic Corp. The recall is being conducted 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 the fact that its vendors were registered and had their own quality systems.
The affected products were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. The recall involves a total of two units.
Consumers and healthcare facilities should stop using the affected saw blades and contact EXP Pharmaceutical Services Corp for further instructions or a return.
The recalled product
- Product
- Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
- 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 5059-531.
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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