Z-0564-2016Class II

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

Name: Z-0564-2016 Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with...
Creator: Biomet 3i, LLC
Published: 2015-11-16
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2015-11-16 / Terminated / root cause: software

FDA source

Biomet 3i, LLC began a recall of Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants on 2015-11-16. FDA classified it as Class II and gives the reason as "Images contained within radiographic transparency ART 1036 are undersized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0564-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-16
Posted: 2015-12-31
Terminated: 2016-12-14
Recalling firm: ZimVie US Corp LLC
Product: Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Images contained within radiographic transparency ART 1036 are undersized.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: BIOMET3i sent an" Urgent Medical Device Recall letter " dated November, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Responsibilities: 1. Please review this notice and check your inventory for the affected item by comparing any on-hand ART 1036 Transparencies to a standard 8.5" x 11" sheet of paper. The non-conforming ART 1036 is approximately 7.8" x 10.2". 2. Immediately quarantine and remove all affected items from service. 3. Complete the attached Business Reply Form and either: a. fax it to 561-514-6316 or b. email it to [email protected] or c. return it along with the affected product using the included shipping label 4. Return affected product to BIOMET 3i. For assistance or other questions that you may have relative to this notice, please contact BIOMET 3i at 1- 800-342-5454 or 1-561-776-6700. Team members are available to assist you 8:00am to 6:00pm (Eastern), Monday through Friday.
Quantity in commerce: 686
Distribution: Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Product codes and lots: Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0564-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0564-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-31

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)