REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL
FDA device recall Z-2051-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.
- Action taken
- ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 28,074 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-31
- Date posted
- 2009-09-09
- Date terminated
- 2011-02-25
- Location
- Largo, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR (K050923) | Conmed Linvatec | 2005-05-18 |