Z-0718-2018Class II

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental...

Name: Z-0718-2018 Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental...
Creator: Keystone Dental Inc
Published: 2017-06-16
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2017-06-16 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or... on 2017-06-16. FDA classified it as Class II and gives the reason as "An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0718-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-16
Posted: 2018-02-26
Terminated: 2019-04-16
Recalling firm: Keystone Dental Inc.
Product: Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Consignees were initially called between June 13, 2017 and June 20, 2017. Customer Relations Fax Back forms were completed to document the phone calls. A notification letter was also sent via FedEx or hand-delivered on 6/19/17. All returned product will be scrapped. For further questions, please call (781) 328-3313.
Quantity in commerce: 72
Distribution: USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada
Product codes and lots: Catalog Number D-TAP-MAX7-7, Lot 31444

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0718-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0718-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-26

Product code DZE

K071161Class IIEndosseous Dental Implant SystemSouthern Implants, Inc. / cleared 2007-11-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)