| Date Initiated by Firm |
February 16, 2018 |
| Create Date |
April 11, 2018 |
| Recall Status1 |
Terminated 3 on June 30, 2020 |
| Recall Number |
Z-1358-2018 |
| Recall Event ID |
79656 |
| Product Classification |
Gag, mouth - Product Code KBN
|
| Product |
Doyen-Collin Mouth Gag 120MM/ General Instruments |
| Code Information |
OM040R |
Recalling Firm/
Manufacturer |
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
|
| For Additional Information Contact |
800-258-1946
|
Manufacturer Reason
for Recall |
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
|
FDA Determined
Cause 2 |
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 |
| Distribution |
nationwide |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
