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[Recalled] CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid a

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductCPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen
Brand / manufacturerZimmer Biomet, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0843-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date11 January 2016
EAN / barcode61790499

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: LDPE bag containing the implant adheres to the highly polished implant surface.

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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