Z-1012-2012

Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01...

Name: Z-1012-2012 Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01...
Creator: Cytophil, Inc
Published: 2012-01-11
License: https://open.fda.gov/license/

Cytophil, Inc / initiated 2012-01-11 / Terminated / root cause: manufacturing process

FDA source

Cytophil, Inc began a recall of Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic... on 2012-01-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1012-2012
Status: Terminated
Initiated: 2012-01-11
Posted: 2012-02-13
Terminated: 2012-05-01
Recalling firm: Cytophil, Inc
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.
Product code: LYC Bone Grafting Material, Synthetic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 547
Distribution: Nationwide Distribution - Including the states of WI, GA, IL, SC, MO, and TX.
Product codes and lots: 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.

Product code LYC

K092788Class IIPeriophil BiphasicCytophil, Inc. / cleared 2009-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)