Medical device recalls Moderate risk

Aesculap Implant Systems LLC recalls Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablat…

Recall date
March 21, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1569-2023
FDA classification
Class II
Brand / firm
Aesculap Implant Systems LLC
Sold / distributed
US Nationwide distribution in the state of OH.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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