Z-2151-2012Class II

PopLok Punch labeled in part: "PKL-35M3.5mmQTY 1PopLok PunchConMed Linvatec Biomaterials, Ltd...

Name: Z-2151-2012 PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2012-07-06
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2012-07-06 / Terminated

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx... on 2012-07-06. FDA classified it as Class II and gives the reason as "ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2151-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-06
Posted: 2012-08-06
Terminated: 2013-11-21
Recalling firm: Linvatec Corporation
Product: PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm.
FDA root cause: Process change control
Action: The recall is being conducted to the end user level. ConMed Linvatec Urgent Medical Device Recall Notifications were sent by FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with the reason for the recall and health risk. All accounts were asked to immediately check their facility for the affected product, stop using any of the product with specified lot number, and to segregate the product. The letter also asked customers to return all affected product to ConMed Linvatec and respond using a Reply Form, even if there is no affected product available. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169.
Quantity in commerce: 2
Distribution: Worldwide Distribution -- US and Korea.
Product codes and lots: Lot 318455

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2151-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2151-2012	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)