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Terminated

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

FDA Recall Z-1179-2018 · Posted None

Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-10-16
Date Terminated2019-04-17
Product Quantity55

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.

Firm 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].

Root Cause

Labeling mix-ups

Distribution Pattern

International Distribution to: Germany only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSLifecore Biomedical, Inc. · 2007-10-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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