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CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to cr...

FDA Recall #Z-2147-2012 — Class II — August 12, 2011

Recall #Z-2147-2012 Date: August 12, 2011 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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.

Recalling Firm

Linvatec Corp. dba ConMed Linvatec — Largo, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2

Distribution

Nationwide Distribution, including the states of Colorado and Pennsylvania.

Code Information

Lot #156920

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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