The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2214-2015·Announced 2015-08-05

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.

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. 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
Category
Medical Device — Orthopedic / Soft Tissue Fixation
Hazard
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

Distributed in 6 states:

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.

See all 42 products in this recall →

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