FDA-Device2012-08-15Class II

CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

Linvatec Corp. dba ConMed Linvatec
Hazard

ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.

Sold states
Nationwide Distribution, including the states of Colorado and Pennsylvania.
Affected count
2
Manufactured in
11311 Concept Blvd, Largo, FL, United States
Products
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2147-2012

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