Recall Z-1358-2018— Aesculap Implant Systems LLC
Class III · Terminated
Class III FDA medical device recall by Aesculap Implant Systems LLC, initiated 2018-02-16, terminated 2020-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Doyen-Collin Mouth Gag 120MM/ General Instruments. Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-02-16
- Terminated
- 2020-06-30
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.