Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery Two-Trigger Modular Handpiece, Mpower PRO6300 Battery Oscillating Saw, Mpower PRO6400 Battery Reciprocating Saw, and Mpower PRO6450 Battery Sternum Saw. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
Recall
- Recall Number
- Z-1952-2009
- Event Number
- 52803
- Firm
- Linvatec Corp. dba ConMed Linvatec
- FEI Number
- 1017294
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 31, 2009
- Posted
- October 1, 2009
- Terminated
- December 19, 2011
- Address
- 11311 Concept Blvd, Largo, FL, 33773-4908
Description
Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery Two-Trigger Modular Handpiece, Mpower PRO6300 Battery Oscillating Saw, Mpower PRO6400 Battery Reciprocating Saw, and Mpower PRO6450 Battery Sternum Saw. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.
There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.
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.
Worldwide Distribution including United States.
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