Z-1358-2018 Class III Terminated
FDA device recall Z-1358-2018 was initiated by Aesculap Implant Systems LLC on Feb 16, 2018 and is designated Class III. Reason for recall: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. The recall status is terminated (terminated Jun 30, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Feb 16, 2018
- Termination Date
- Jun 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason for Recall
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Distribution Pattern
nationwide
Code Information
OM040R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1358-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026