Z-0282-2018Class II

Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT...

Name: Z-0282-2018 Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT...
Creator: Zimmer Dental Inc
Published: 2017-10-11
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2017-10-11 / Terminated / root cause: manufacturing process

FDA source

Zimmer Dental Inc began a recall of Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by... on 2017-10-11. FDA classified it as Class II and gives the reason as "The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0282-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-11
Posted: 2017-12-21
Terminated: 2019-03-13
Recalling firm: ZimVie US Corp LLC
Product: Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm, Zimmer Biomet, issued "URGENT MEDICAL DEVICE RECALL" letters addressed to Clinicians dated 10/11/2017 via FedEx on 10/11/2017. Letters to the distributors dated 10/11/2017 were issued via courier or email on 10/11/2017. The letters described the product, problem and actions to be taken. The customers were instructed to review notification for awareness; review your inventory; immediately return all affected product from your facility to: Field Action PM Regulatory Compliance Zimmer Biomet 4555 Riverside Dr. Palm Beach Gardens, FL 33410 US and complete and return the Certificate of Acknowledgment by fax to 574-372-4265 or email: [email protected]. If you have further questions or concerns after reviewing this notice, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 891 kits
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.
Product codes and lots: Lot numbers 63581758, 63583277, 63587717, 63623845, 63632463, 63632464, 63666560, 63669280, 63676567, 63676568, 63693941, 63694051, 63715410, 63716081, 63724569, 63724570, 63728840, 63735508, 63735987, 63739443, 63743229, 63748227, and 63750186

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0279-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21
Z-0280-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21
Z-0281-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21
Z-0282-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-21

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)