# FDA recall Z-0059-2018

> **Teleflex Medical** · Class II · device recall initiated 2017-10-18.

## Product

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components:  (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5  (b) 5 mm Maryland Dissector, Catalog Number PCVMD5  (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5  (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5  (e) 5 mm Scissors, Catalog Number PCVSC5    The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connect

## Reason for recall

Teleflex is recalling these products because the jaws of the tool tip may break,  causing a fragment of the tool tip to fall off during use.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Australia, Belgium, Hong Kong, Japan, S. Korea and  Singapore.

## Key facts

- **Recall number:** Z-0059-2018
- **Recalling firm:** Teleflex Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-18
- **Report date:** 2017-11-08
- **Termination date:** 2020-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Research Triangle Park, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0059-2018

## Citation

> AI Analytics. FDA recall Z-0059-2018. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0059-2018. Source: US FDA. Licensed CC0.

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