September 2002 AAOS Report
FDA recall of human tissue processed by Cryolife, Inc.
On Aug. 14, 2002, the Food and Drug Administration (FDA) ordered Cryolife, Inc. to recall human tissue processed from Oct. 3, 2001 to the present. The FDA has determined that Cryolife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants. Symptoms from a bacterial or fungal infection usually appear within days or weeks following transplantation. Therefore, it is unlikely that patients who have not recently received a transplant are at future risk. If physicians suspect an infection from allograft tissue, they should treat it accordingly and report the case to the FDA Surveillance System:
- Medwatch: Visit the Web site, www.fda.gov/medwatch/report/hcp.htm
and complete the voluntary Form 3500 online. Your report will be available to safety evaluators within several days.
- Food and Drug Administration (FDA): (301) 827-2000 or (800) 835-4709
- Centers of Disease Control (CDC): (800) 893-0485
The Academy urges all Fellows to discuss this situation with their patients who have recently received tissue transplants. Any Fellow who works with a hospital or medical center that uses tissues from Cryolife, Inc. is urged to take appropriate action to ensure that the FDA recall order is followed. In particular, the FDA suggests that any suspect tissue be quarantined.
AAOS also recommends that Fellows familiarize themselves with the following AAOS Advisory Statements:
- The Use of Allograft Tissue
- Implant Device Recalls