Device product
Percuvance 29cm Shaft 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.
Z-3224-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 77974
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,039 Total (US and OUS)
- Official record key
device-enforcement:Z-3224-2017
Official wording
Reason: 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.
Code information: Lot #'s: 73B1600168, 73B1700525, 73C1600057, 73C1600152, 73C1600267, 73C1600327, 73D1600176, 73D1600481, 73E1600001, 73E1600662, 73F1600520, 73F1600594, 73F1600697, 73G1600015, 73G1600177, 73G1600178, 73G1600557, 73G1600730, 73H1600567, 73J1600182, 73M1600025, 73M1600026, 73M1600232, 73M1600233, and 73M1600328.
Distribution pattern: 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
Derived failure modes
-
Unknown
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.