Aesculap Implant Systems LLC: Medical Device Recall in 2018 - (Recall #: Z-1358-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Doyen-Collin Mouth Gag 120MM/ General Instruments

Product Classification:

Class III

Date Initiated: February 16, 2018

Date Posted: April 18, 2018

Recall Number: Z-1358-2018

Event ID: 79656

Reason for Recall:

The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.

Status: Terminated

Product Quantity:

Code Information:

OM040R

Distribution Pattern:

nationwide

Voluntary or Mandated:

Voluntary: Firm initiated