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U.S. Department of Health and Human Services

Class 2 Device Recall CAIMAN MARYLAND ARTICULATING D5/360MM

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  Class 2 Device Recall CAIMAN MARYLAND ARTICULATING D5/360MM see related information
Date Initiated by Firm March 21, 2023
Date Posted May 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-1569-2023
Recall Event ID 92079
510(K)Number K183180  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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
Code Information UDI-DI: 04046964837340 Lot Number: 52785146
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact SAME
800-258-1946
Manufacturer 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.
FDA Determined
Cause 2		 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. 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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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.
Quantity in Commerce 6 pieces
Distribution US Nationwide distribution in the state of OH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Aesculap, Inc.
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