Device 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
Z-0651-2013
Product summary
- Event
- Event 63226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-0651-2013
Official wording
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.
Code information: Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119
Distribution pattern: Worldwide Distribution including Turkey, Greece, & Mexico.
Derived failure modes
-
Foreign material or chemical contamination
particulates