FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: Doyen-Collin Mouth Gag 120MM/ General Instruments
- Recall number
- Z-1358-2018
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- Doyen-Collin Mouth Gag 120MM/ General Instruments
- Status
- Terminated
- Initiated
- 2018-02-16
- Posted
- not on file
- Terminated
- 2020-06-30
- Reason
- The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
- Root cause
- 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
- Quantity
- not on file
- Distribution
- nationwide
- Lot, serial or model codes
- OM040R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KBN
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28