Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase B
FDA device recall Z-1012-2012 · posted 2012-02-13 · Terminated
Recall details
- Recalling firm
- Cytophil, Inc
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LYC
- Quantity affected
- 547
- Distribution
- Nationwide Distribution - Including the states of WI, GA, IL, SC, MO, and TX.
- Date initiated
- 2012-01-11
- Date posted
- 2012-02-13
- Date terminated
- 2012-05-01
- Location
- East Troy, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERIOPHIL BIPHASIC (K092788) | Cytophil, Inc. | 2009-12-18 |