CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate

FDA device recall Z-2147-2012 · posted 2012-08-06 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

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.

Action taken

The firm sent an "URGENT: Medical Device Recall Notification" letter dated August 12, 2011, to its customers after initial phone notifications. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1) Immediately check their facility's inventory for the product number and lot number listed in the letter. If the product is at their facility, they were instructed to discontinue the use of the product. 2) To return the products to ConMed Linvatec for credit and return the products and Reply Form. 3) If the product was transferred to another facility, complete the Reply Form documenting the transfer of the product, and return i by mail or fax. For questions, contact 727-399-5205.

Root cause

Use error

Status

Terminated

Product code

LXH

Quantity affected

2

Distribution

Nationwide Distribution, including the states of Colorado and Pennsylvania.

Date initiated

2011-08-12

Date posted

2012-08-06

Date terminated

2013-11-21

Location

Largo, FL