Recall Z-1527-2014 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Laurimed LLC
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.
| Date | Apr 30, 2014 (initiated Apr 7, 2014) |
| Status | Terminated |
| Reason | The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. |
| Root cause | Component design/selection |
| Action | All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to bdubois@laurimed.com or 650-587-5296. |
| Quantity | 58 |
| Distribution | Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER Laurimed, LLC, Dec 23, 2013 |