FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
- Recall number
- Z-2533-2017
- Recalling firm
- Applied Medical Resources Corp
- Product
- Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
- Status
- Terminated
- Initiated
- 2017-05-04
- Posted
- 2017-06-14
- Terminated
- 2018-03-06
- Reason
- Due to possibility of insufficient sterilization.
- Root cause
- 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
- 7,939 units total (870 units in US)
- Distribution
- US and worldwide: Australia, Finland, France, United Kingdom
- Lot, serial or model codes
- CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
- 510(k) numbers
- ["K060096","K072674"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28