Device Recall PopLok Punch 3.5MM 의 리콜

Recall

63823

Class 2

Z-0789-2013

2012-11-15

2013-02-05

Terminated

United States

2013-05-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114837

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.

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.