Food, drugs, devices › Aesculap Implant Systems LLC
Device recall: Doyen-Collin Mouth Gag 120MM/ General Instruments
Aesculap Implant Systems LLC (Center Valley, PA) initiated this device recall on 16 Feb 2018; FDA lists 2 product records under event 79656, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 30 Jun 2020. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap Implant Systems LLC, Center Valley, PA.
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
"nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1358-2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | — | Class III | Terminated | 18 Apr 2018 |
| Z-1359-2018 | Strauss Penis Clamp 130MM/General Instruments | — | Class III | Terminated | 18 Apr 2018 |
Context
Other enforcement events for Aesculap Implant Systems LLC
All 35 events for Aesculap Implant Systems LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.