Z-0164-2013Class II

"All in one CrossFTPunchPFT-00M4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL...

Name: Z-0164-2013 "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2012-04-09
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2012-04-09 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of "***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... on 2012-04-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0164-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-09
Posted: 2012-10-29
Terminated: 2013-11-21
Recalling firm: Linvatec Corporation
Product: "***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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Linvatec Corp sent a Urgent Medical Device Recall Notification letter dated April 9, 2012, to all affected customers. The letter was sent via FEDEx and by e-mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory for the recalled product and segregate them for return to the recalling firm. Furthermore, return the products along with the "REPLY FORM". Should you have any further questions please contact our Customer Service department at (800) 237-0169.
Quantity in commerce: 2 units
Distribution: Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Product codes and lots: Lot # 330889 and Catalog: PFT-00M - No Expiration date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0164-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0164-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-29

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)