The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2042-2017·Announced 2017-05-17

Arthrex Recalls Anthrex PEEK SwiveLock SP Vented Anchors Due to Breakage

Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion. The recall covers units distributed in the US and several international locations.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to adverse health consequences.

Plain-English summary

Arthrex, Inc. is recalling the Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching anchor. The recall was initiated because some eyelets broke from the SwiveLock Anchor during insertion. This is an FDA Class II recall, which indicates that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected product is identified by the Unique Device Identifier 00888867026803, Batch Number 10078258, and an expiration date of 12/01/2021. The distribution pattern includes numerous US states, Puerto Rico, and several international locations including Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay, and Japan (DOD).

Healthcare providers and patients should stop using the affected anchors and contact Arthrex, Inc. for further instructions or a replacement. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching
Manufacturer
Arthrex, Inc.
Category
Medical Device — Orthopedic Anchor
Hazard

Distribution

Distributed in 49 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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