Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery Two-Trigger Modular Handpiece, Mpower PRO6300 Ba
FDA device recall Z-1952-2009 · posted 2009-10-01 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.
- Action taken
- Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169. Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 1,388
- Distribution
- Worldwide Distribution including United States.
- Date initiated
- 2009-07-31
- Date posted
- 2009-10-01
- Date terminated
- 2011-12-19
- Location
- Largo, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIVERSAL DRIVE SYSTEM (K981269) | Linvatec Corp. | 1998-06-24 |