Percuvance(R) Percutaneous Shaft 29cm recall
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended…
Why was Percuvance(R) Percutaneous Shaft 29cm recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch/Lot Numbers: 73A1700531, 73B1700180, 73F1700583, 73F1700584, 73F1700585, 73H1700728, 73J1600394, 73J1700072, 73J1700073, 73J1700074, 73J1700554
- Product
- Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended…
- Recalling firm
- Teleflex Medical
- Quantity
- 1751 units
- Distribution
- 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.
- Recall date
- January 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)