RecallRadar

FDA Device recall Z-0564-2016

Radiographic Transparency for Certain and External Connection Tapered Implants

On 2016-01-06 the FDA classified a Class II recall of Radiographic Transparency for Certain and External Connection Tapered Implants by Biomet 3i, citing images contained within radiographic transparency ART 1036 are undersized.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0564-2016
ClassificationClass II
Statusterminated
Initiated2015-11-16
Published2016-01-06
Last updated2026-09-13 11:54 UTC
CompanyBiomet 3i
DistributionCA, CO, FL, HI, IL, MA, MI, MO, NY, OH, PR, SC, TX, VA, WI, WV

Product

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

Reason

Images contained within radiographic transparency ART 1036 are undersized.

Identifiers

code_infoModel Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.

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-0564-2016%22

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