Class 2 Device Recall Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic

• Date Initiated by Firm: January 11, 2012
• Date Posted: February 13, 2012
• Recall Status: Terminated on May 01, 2012
• Recall Number: Z-1012-2012
• Recall Event ID: 61044
• 510(K)Number: K092788
• Product Classification: Bone grafting material, synthetic - Product Code LYC
• Product: Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120.
• Code Information: 1. 03001-02 Periophil Biphasic, Lot # Z13-927A, expiration date 2/1/2014. 2. 03001-02 Periophil Biphasic, Lot # Z13-927B, expiration date 2/1/2014. 3. 03001-01 Periophil Biphasic, Lot # Z13-926A, expiration date 2/1/2014. 4. 03001-01 Periophil Biphasic, Lot # N13-925C, expiration date 1/31/2014. 5. 03003-01 Periobase Biphasic, Lot # N13-925B, expiration date 1/31/2014. 6. 03002-01 Periobone Biphasic, Lot # N13-925A, expiration date 1/31/2012.
• FEI Number: 3007225376
• Recalling Firm/ Manufacturer: Cytophil, Inc; 2485 Corporate Cir Ste 2; East Troy WI 53120-2577
• For Additional Information Contact: 262-642-2765
• Manufacturer Reason for Recall: Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.
• FDA Determined Cause: Process control
• Action: Consignees were sent an "Urgent Medical Device Recall" letter dated January 11, 2012 by Cytophil. The letter described the problem and the product involved in the recall. The firm advised consignees to immediately examine their inventory and quarantine product subject to recall. In addition, if they have further distributed this product, they were requested to identify their customers and notify them at once of this product recall. For questions, call 262-642-2765.
• Quantity in Commerce: 547
• Distribution: Nationwide Distribution - Including the states of WI, GA, IL, SC, MO, and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LYC