Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute

FDA device recall Z-1746-2011 · posted 2011-03-23 · Terminated

Recall details

Recalling firm

Organogenesis, Inc.

Reason for recall

Product sterility compromised

Action taken

Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis

Root cause

Material/Component Contamination

Status

Terminated

Product code

MGR

Quantity affected

50 units

Distribution

nationwide.

Date initiated

2011-01-30

Date posted

2011-03-23

Date terminated

2011-07-28

Location

Canton, MA