Z-0753-2019 Class II Terminated
FDA device recall Z-0753-2019 was initiated by Teleflex Medical on Jan 3, 2018 and is designated Class II. Reason for recall: There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and… The recall status is terminated (terminated Oct 30, 2020). Affected quantity: 1751 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 30, 2019
- Initiation Date
- Jan 3, 2018
- Termination Date
- Oct 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1751 units
Product Description
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: 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.
Reason for Recall
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.
Code Information
Batch/Lot Numbers: 73A1700531, 73B1700180, 73F1700583, 73F1700584, 73F1700585, 73H1700728, 73J1600394, 73J1700072, 73J1700073, 73J1700074, 73J1700554
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0753-2019
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026