Skip to content
Recall Observatory FDA recall evidence

Device product

Percuvance Maryland Dissector 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.

Z-3222-2017

July 19, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 77974
Status
Terminated
Classification
Class II
Quantity
20,039 (US and OUS)
Official record key
device-enforcement:Z-3222-2017

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: 73D1600174, 73D1600587, 73E1600661, 73F1600015, 73G1600729, 73H1600012, 73H1600149, 73H1600341, 73H1600902, 73J1600062, 73L1600025, 73L1600210, 73L1600445, 73M1500036, and 73M1500036

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

    reason.no_named_rule · v1.0.0

    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.