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[Recalled] Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision ar

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductCharnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical p
Brand / manufacturerDePuy Orthopaedics, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0061-2015
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date27 August 2014
EAN / barcode10603295240532

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.

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 DePuy Orthopaedics, 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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