Recall Z-1569-2023— Aesculap Implant Systems LLC
Class II · Ongoing
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2023-03-21. It names one FDA 510(k) clearance: K183180. Product: 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: 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..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-21
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.