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U.S. Department of Health and Human Services

Class 2 Device Recall Kii Shielded Bladed Access System and Kii Low Profile System

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  Class 2 Device Recall Kii Shielded Bladed Access System and Kii Low Profile System see related information
Date Initiated by Firm May 04, 2017
Date Posted June 14, 2017
Recall Status1 Terminated 3 on March 06, 2018
Recall Number Z-2533-2017
Recall Event ID 77277
510(K)Number K060096  K072674  
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
Product Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and
Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Code Information CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact
949-713-8000
Manufacturer Reason
for Recall		 Due to possibility of insufficient sterilization.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60738625@appliedmedical.com or faxing to 949-713-8847. The recall letter instructs the customers that for product return questions to contact Karen Mitchell, Associate Manager Sales Operations, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at contursi@appliedmedical.com. On 8/21/17 an Urgent Medical Device recall letter was sent to their customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of the Kii trocar model, CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. During shipment, the trocar packaging has the potential to become punctured with small holes, which would compromise the sterile barrier.
Quantity in Commerce 7,939 units total (870 units in US)
Distribution US and worldwide: Australia, Finland, France, United Kingdom
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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