EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure
EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors 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 classified as FDA Class II. The source text identifies a regulatory compliance failure (lack of registration and quality system) rather than a specific product defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew FT, Vented Suture Anchors (OEM Catalog number AR-1927BCF). The devices are sterile, single-use fasteners used for soft tissue fixation. The recall is limited to one unit.
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 were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas. Consumers and healthcare providers should stop using the recalled devices and contact EXP Pharmaceutical Services Corp for further instructions.
The recalled product
- Product
- Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 1
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 AR-1927BCF.
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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