Z-2533-2017Class II

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual...

Name: Z-2533-2017 Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual...
Creator: Applied Medical Resources Corp
Published: 2017-05-04
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2017-05-04 / Terminated / root cause: sterility

FDA source

Applied Medical Resources Corp began a recall of Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars on 2017-05-04. FDA classified it as Class II and gives the reason as "Due to possibility of insufficient sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2533-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-04
Posted: 2017-06-14
Terminated: 2018-03-06
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Due to possibility of insufficient sterilization.
Root cause tag: sterility
FDA 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 [email protected] 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 [email protected]. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at [email protected]. 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
Product codes and lots: CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2533-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2533-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-13

Product code GCJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)