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[Recalled] Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 005

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductVarious Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201 00585001202 00585001301 00585001302 00585003038 00585003214 00585003217 00585003219 00585003238 00585003246 00585004445 00585004455 00585004465 00585004603 00585004604 00585004605 00585004606 005850046
Brand / manufacturerZimmer Biomet, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0323-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date10 October 2019
EAN / barcode00585000011

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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 Zimmer 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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