Z-0113-2017Class II

Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable)...

Name: Z-0113-2017 Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable)...
Creator: Osteogenics Biomedical, Inc.
Published: 2016-09-07
License: https://open.fda.gov/license/

Osteogenics Biomedical, Inc. / initiated 2016-09-07 / Terminated / root cause: labeling and UDI

FDA source

Osteogenics Biomedical, Inc. began a recall of Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment... on 2016-09-07. FDA classified it as Class II and gives the reason as "The device has the potential to be packaged in the wrong product box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0113-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Posted: 2016-10-18
Terminated: 2016-12-23
Recalling firm: Osteogenics Biomedical, Inc.
Product: Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
Product code: LYC Bone Grafting Material, Synthetic
Reason for recall: The device has the potential to be packaged in the wrong product box.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Osteogenics Biomedical sent an Urgent Customer Notification letter dated September 7, 2016, to all affected customers. This recall has been extended to the user level (clinician). All units sold domestically were to the end users (clinicians). End users were instructed to inspect inventory and return any affected product. For further questions, please call 1-888- 796-1923.
Quantity in commerce: 32 boxes
Distribution: Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
Product codes and lots: Lot 47295

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code LYC

K972278Class IICytoplast Regentex Titanium 250Osteogenics Co. / cleared 1997-08-06

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)