Recall Z-0113-2017— Osteogenics Biomedical, Inc.

Name: FDA recall Z-0113-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-07

Class II · Terminated

Class II FDA medical device recall by Osteogenics Biomedical, Inc., initiated 2016-09-07, terminated 2016-12-23. It names one FDA 510(k) clearance: K972278. 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.. Reason: The device has the potential to be packaged in the wrong product box..

Recalling firm: Osteogenics Biomedical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-09-07
Terminated: 2016-12-23
Firm location: Lubbock, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K972278 — CYTOPLAST REGENTEX TITANIUM 250Osteogenics Co.·cleared 1997-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The device has the potential to be packaged in the wrong product box.

Data sourced from openFDA. This site is unofficial and independent of the FDA.