FDA Medical Device Recalls (openFDA)
Surgical Tissue Network, Inc.: Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
- Recall number
- Z-0651-2013
- Recalling firm
- Surgical Tissue Network, Inc.
- Product
- Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler
- Status
- Terminated
- Initiated
- 2012-03-14
- Posted
- 2013-01-07
- Terminated
- 2014-12-02
- Reason
- 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.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 25 units
- Distribution
- Worldwide Distribution including Turkey, Greece, & Mexico.
- Lot, serial or model codes
- Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3003564213
- Firm city
- Orlando
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28