Recall Z-1359-2018 ยท FHA Clamp, Penile
Aesculap Implant Systems LLC
Strauss Penis Clamp 130MM/General Instruments
| Date | Feb 16, 2018 |
| Status | Terminated |
| 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 |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.