The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1960-2016·Announced 2016-06-22

Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate

Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implantable medical device) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.

Plain-English summary

Arthrex, Inc. is recalling 138 units of the BioSync Anatomic Cotton Wedge, 16 x 6.5 mm. The recall is due to the potential for polystyrene particulate presence in the devices. These medical devices are used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot.

The affected products are identified by Catalog Number AR-8948W-1665, Batch Number 10020489, and Unique Device Identifier 00888867202726. The devices were distributed in the states of California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington, and Wisconsin.

The U.S. Food and Drug Administration has classified this recall as Class II. Healthcare providers and patients should contact Arthrex, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Manufacturer
Arthrex, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
138

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 (3)

  • Catalog #: AR-8948W-1665
  • Batch #: 10020489
  • Unique Device Identifier: 00888867202726.

Distribution

Distributed in 15 states:

Part of a larger recall action

This product is one of 6 recalled by Arthrex, Inc. 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 6 products in this recall →

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