Z-1569-2023 Class II Ongoing
FDA device recall Z-1569-2023 was initiated by Aesculap Implant Systems LLC on March 21, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 6 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2023
- Initiation Date
- March 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 pieces
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of OH.
Code Information
UDI-DI: 04046964837340 Lot Number: 52785146