RecallRadar

FDA Device recall Z-0113-2017

Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barr…

On 2016-10-26 the FDA classified a Class II recall of Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barr… by Osteogenics Biomedical, citing the device has the potential to be packaged in the wrong product box.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0113-2017
ClassificationClass II
Statusterminated
Initiated2016-09-07
Published2016-10-26
Last updated2026-09-13 11:54 UTC
CompanyOsteogenics Biomedical
Distributionn/a

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.

Identifiers

code_infoLot 47295

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0113-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.