EXP Recalls Unregistered Stryker Femoral Canal Tips
EXP Pharmaceutical Services Corp is recalling 12 Stryker Femoral Canal Tips 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 driven by regulatory non-compliance (failure to register and establish a quality system) rather than a specific product defect or reported illness, fitting the criteria for a moderate severity voluntary precautionary or administrative recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 12 units of Stryker Femoral Canal Tips (OEM Catalog number 210-8-N). These sterile, single-use medical devices 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, 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. This failure to comply with regulatory requirements necessitates the recall of the affected units.
Consumers and healthcare facilities should stop using these devices immediately and contact EXP Pharmaceutical Services Corp for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text, but the lack of proper registration and quality system oversight presents a regulatory and safety concern.
The recalled product
- Product
- Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
- Manufacturer
- EXP Pharmaceutical Services Corp
- Category
- Medical Device — Orthopedic
- Affected units
- 12
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 210-8-N.
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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