STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Recall
- Recall Number
- Z-1179-2018
- Event Number
- 79297
- Firm
- Keystone Dental Inc
- FEI Number
- 3005990499
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- October 16, 2017
- Terminated
- April 17, 2019
- Address
- 154 Middlesex Tpke, Burlington, MA, 01803-4403
Description
STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
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.
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].
International Distribution to: Germany only.
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