Z-3220-2017Class II

Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the...

Name: Z-3220-2017 Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the...
Creator: Teleflex Medical
Published: 2017-07-19
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-07-19 / Terminated / root cause: design

FDA source

Teleflex Medical began a recall of Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain... on 2017-07-19. FDA classified it as Class II and gives the reason as "For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3220-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-19
Posted: 2017-09-27
Terminated: 2020-10-06
Recalling firm: Teleflex Medical
Product: Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
Root cause tag: design
FDA root cause: Device Design
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated July 19 , 2017, to all affected consignees communicating the following on their recall of Percuvance Percutaneous Surgical System: Consignees were advised to take the following actions. 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter. Customers with any other questions, should contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 20,039 total (US and OUS)
Distribution: Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
Product codes and lots: Lot #'s: 73A1600601, 73A1700239, 73C1600705, 73E1600177, 73E1600177, 73E1600341, 73F1600411, 73F1600695, 73G1600727, 73H1600151, 73H1600342, and 73H1600660

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3220-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3219-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3220-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3221-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3222-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3223-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3224-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27

Product code GEI

K153063Class IIPercuvance Percutaneous Surgical SystemTeleflexmedical, Inc. / cleared 2016-04-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)