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[Recalled] Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures — There were complaints indicating that when the product was opened in surgery, t… | FDA 2018-08-0

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

ProductAffixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Brand / manufacturerZimmer Biomet, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0156-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date08 August 2018
EAN / barcode814413360

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.

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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