Home › CYTOPHIL, INC. › Implant Logistics Synthetic Biphasic Dental Bone Graft Granules

Implant Logistics Synthetic Biphasic Dental Bone Graft Granules

CYTOPHIL, INC. · Model 03-010-01-MIL · UDI-DI 00852108006114

LYC Prescription

510(k) clearances

513

Adverse events (1 deaths)

Recalls

Facilities

Description

Synthetic bone graft substitute in particulate form composed of biphasic calcium phosphate intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects that are surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Recalls

Date	Firm	Reason
2018-08-16	Collagen Matrix, Inc.	There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only
2016-09-07	Osteogenics Biomedical, Inc.	The device has the potential to be packaged in the wrong product box.
2016-01-21	Biomet France SARL	Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
2013-10-03	Biomet 3i, LLC	Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2012-10-25	Kerr Corporation	The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
2012-01-11	Cytophil, Inc	Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an in
2010-05-14	Ace Surgical Supply Co., Inc.	Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risk

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.