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[Recalled] "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. — ConMed Linvatec is recalling the

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

Product"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Brand / manufacturerLinvatec Corp. dba ConMed Linvatec
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0164-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date09 April 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.

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 Linvatec Corp. dba ConMed Linvatec

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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