Stage1 Dental Implant 의 리콜

Recall

79297

Class 3

Z-1179-2018

2017-10-16

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161839

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 CustomerSupport@KeystoneDental.com.