Recall Z-1527-2014— Laurimed LLC
Class III · Terminated
Class III FDA medical device recall by Laurimed LLC, initiated 2014-04-07, terminated 2014-05-14. It names one FDA 510(k) clearance: K133133. Product: PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.. Reason: The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle..
- Recalling firm
- Laurimed LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-04-07
- Terminated
- 2014-05-14
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Reason for recall
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.