Z-2147-2012Class II

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

Name: Z-2147-2012 CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2011-08-12
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2011-08-12 / Terminated

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of 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... on 2011-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2147-2012
Classification: Class II
Status: Terminated
Initiated: 2011-08-12
Posted: 2012-08-06
Terminated: 2013-11-21
Recalling firm: Linvatec Corporation
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
FDA root cause: Use error
Action: 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.
Quantity in commerce: 2
Distribution: Nationwide Distribution, including the states of Colorado and Pennsylvania.
Product codes and lots: Lot #156920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2147-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2147-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-06

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)