Recall Z-1569-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aesculap Implant Systems LLC
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
| Date | May 5, 2023 (initiated Mar 21, 2023) |
| Status | Open, Classified |
| Reason | Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body. |
| Root cause | Device Design |
| Action | Aesculap Inc. issued via Urgent Medical Device Recall Notification Letter via U.S Postal Service, Certified Mail Return Receipt Requested/ USPS Priority Mail on 3/21/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Det |
| Quantity | 6 pieces |
| Distribution | US Nationwide distribution in the state of OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183180 | Caiman 5 Maryland Aesculap, Inc., Mar 12, 2019 |