FDA-Device2012-11-07Class II
"***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.
Linvatec Corp. dba ConMed Linvatec
Hazard
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.
Sold states
Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Affected count
2 units
Manufactured in
11311 Concept Blvd, N/A, Largo, FL, United States
Products
"***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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2013Don't want to check this manually?
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