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

FDA device recall Z-0789-2013 · posted 2013-02-05 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

LXH

Quantity affected

8

Distribution

Worldwide Distribution - USA including California and Internationally to Spain and Korea

Date initiated

2012-11-15

Date posted

2013-02-05

Date terminated

2013-05-22

Location

Largo, FL