Z-1179-2018Class III

STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Name: Z-1179-2018 STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Creator: Keystone Dental Inc
Published: 2017-10-16
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2017-10-16 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K on 2017-10-16. FDA classified it as Class III and gives the reason as "A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve". 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-1179-2018
Classification: Class III
Status: Terminated
Initiated: 2017-10-16
Posted: 2018-03-24
Terminated: 2019-04-17
Recalling firm: Keystone Dental Inc.
Product: STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Keystone Dental, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/24/217 to its consignee. The letter described the product, problem and actions to be taken. The consignee was instructed to do the following: Return any product remaining in inventory to Keystone Dental and replacement product will be sent to you. Note: These lots were the only affected product and all other inventory you may have can be used. Complete and return the Customer Relations Fax Back Form to Customer Relations (1-866-903-9272-US only/ 1-781-328-3400). If you have any questions, please contact Customer Relations Manager at: Toll Free 866-902-9272; Fax 866-903-9272 and [email protected].
Quantity in commerce: 55
Distribution: International Distribution to: Germany only.
Product codes and lots: Lots: 35026, 35579, 36133

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1179-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1179-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-24

Product code DZE

K072768Class IIRestore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc. / cleared 2007-10-23

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)