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U.S. Department of Health and Human Services

Class 3 Device Recall DoyenCollin Mouth Gag 120MM/ General Instruments

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  Class 3 Device Recall DoyenCollin Mouth Gag 120MM/ General Instruments see related information
Date Initiated by Firm February 16, 2018
Create Date April 11, 2018
Recall Status1 Terminated 3 on June 30, 2020
Recall Number Z-1358-2018
Recall Event ID 79656
Product Classification Gag, mouth - Product Code KBN
Product Doyen-Collin Mouth Gag 120MM/ General Instruments
Code Information OM040R
Recalling Firm/
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
Manufacturer Reason
for Recall
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
FDA Determined
Cause 2
Mixed-up of materials/components
Action An Urgent Medical Device Recall notification will be sent via Fed-ex overnight to our customers on February 16, 2018. Customers will be required to review the recall notification letter in its entirety and ensure all users in the organization are informed about this recall and the affected products
Distribution nationwide
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.