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.
FDA Recall Z-1952-2009 · Posted 2009-10-01
Advertisement
Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeHRX
Date Initiated2009-07-31
Date Terminated2011-12-19
Product Quantity1,388
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution including United States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement