FDA Medical Device Recalls (openFDA)
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 material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120.
- Recall number
- Z-1012-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-01-11
- Posted
- 2012-02-13
- Terminated
- 2012-05-01
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K092788"]
- PMA numbers
- not on file
- Product code
- LYC
- Firm FEI
- 3007225376
- Firm city
- East Troy
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28