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U.S. Department of Health and Human Services

Class 3 Device Recall Stage1 Dental Implant

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  Class 3 Device Recall Stage1 Dental Implant see related information
Date Initiated by Firm October 16, 2017
Create Date March 24, 2018
Recall Status1 Terminated 3 on April 17, 2019
Recall Number Z-1179-2018
Recall Event ID 79297
510(K)Number K072768  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Code Information Lots: 35026, 35579, 36133
Recalling Firm/
Manufacturer		 Keystone Dental Inc
154 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact Saba Shahid
781-328-3313
Manufacturer 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.
FDA Determined
Cause 2		 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 CustomerSupport@KeystoneDental.com.
Quantity in Commerce 55
Distribution International Distribution to: Germany only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = LIFECORE BIOMEDICAL, INC.
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