Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard ther

FDA device recall Z-2589-2010 · posted 2010-09-28 · Terminated

Recall details

Recalling firm

Organogenesis, Inc.

Reason for recall

Product is contaminated with a yeast identified as Pseudozyma antarctica.

Action taken

Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.

Root cause

Process control

Status

Terminated

Product code

MGR

Quantity affected

32 units

Distribution

Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.

Date initiated

2010-08-02

Date posted

2010-09-28

Date terminated

2011-03-10

Location

Canton, MA