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Aesculap Caiman Articulating D5/360MM - An electrosurgical… recallZ-1569-2023 · Aesculap Implant Systems LLC · initiated Mar 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

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. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached Product Recall Acknowledgement Form, record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Recall Acknowledgment Form form to the B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Acknowledgement Form, an Aesculap Customer Support representative will contact you to arrange for credit and to have your current inventory returned. Should you identify a problem or safety concern with the product, please report the event promptly by contacting our Postmarket Surveillance Department at 1-833-425-1464.

Recall details

Recall number
Z-1569-2023
Status
Open, Classified
Initiated by the company
Mar 21, 2023
Posted by the FDA
May 5, 2023
Recalling firm
Aesculap Implant Systems LLC
Quantity
6 pieces
Product code
GEI
FDA submissions
K183180
Distribution
US Nationwide distribution in the state of OH.

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

Code information (models, lots, serial numbers)

UDI-DI: 04046964837340 Lot Number: 52785146

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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