Z-0789-2013Class II

ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone...

Name: Z-0789-2013 ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2012-11-15
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2012-11-15 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch on 2012-11-15. FDA classified it as Class II and gives the reason as "ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm". 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-0789-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-15
Posted: 2013-02-05
Terminated: 2013-05-22
Recalling firm: Linvatec Corporation
Product: ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ConMed Linvatech issued a "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to its customers on November 15, 2012 for a recall that was conducted at the end user/distributor level. All recall notifications were sent FedEx next day delivery or equivalent method to notify all direct consignees. The notifications identified the affected product along with reason for the recall 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. If customers have any additional questions, they should contact the Customer Service department at 800-237-0169. For questions regarding this recall call 727-399-5205.
Quantity in commerce: 8
Distribution: Worldwide Distribution - USA including California and Internationally to Spain and Korea
Product codes and lots: Lot 256058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0789-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-05

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)