UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010

FDA device recall Z-0653-2013 · posted 2013-01-07 · Terminated

Recall details

Recalling firm

Surgical Tissue Network, Inc.

Reason for recall

Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.

Action taken

Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers. Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230. For questions regarding this recall call 407-380-2424.

Root cause

Employee error

Status

Terminated

Product code

MQV

Quantity affected

160 units

Distribution

Worldwide Distribution including Turkey, Greece, & Mexico.

Date initiated

2012-03-14

Date posted

2013-01-07

Date terminated

2014-12-02

Location

Orlando, FL