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[Recalled] Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568 — Anchor plugs potentially have metal burrs in the transverse holes o

recall fda device united-states

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

Recall details

ProductCompress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
Brand / manufacturerBiomet, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0387-2024
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date09 October 2023
EAN / barcode00880304461611

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

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 Biomet, Inc.

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.

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