Recall Z-1179-2018 ยท DZE Implant, Endosseous, Root-Form
Keystone Dental Inc
STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
| Date | Oct 16, 2017 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 55 |
| Distribution | International Distribution to: Germany only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS Lifecore Biomedical, Inc., Oct 23, 2007 |