[Recalled] Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching — Some eyelets broke from SwiveLock Anchor on insertion | FDA 2017-03-24

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Some eyelets broke from SwiveLock Anchor on insertion.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Arthrex, Inc.

• 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. — Class II
• BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. — Class II
• Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching — Class II
• K-Wire, 1.35 mm x 170 mm — Class II
• Arthrex Suture Washer — Class III
• Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.