Recall Z-1012-2012 ยท LYC Bone Grafting Material, Synthetic
Cytophil, Inc
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 materia
| Date | Feb 13, 2012 (initiated Jan 11, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 547 |
| Distribution | Nationwide Distribution - Including the states of WI, GA, IL, SC, MO, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092788 | PERIOPHIL BIPHASIC Cytophil, Inc., Dec 18, 2009 |