Recall Z-1952-2009 ยท HRX Arthroscope
Linvatec Corp. dba ConMed Linvatec
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.
| Date | Oct 1, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008. |
| Root cause | Device Design |
| 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 speci |
| Quantity | 1,388 |
| Distribution | Worldwide Distribution including United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981269 | UNIVERSAL DRIVE SYSTEM Linvatec Corp., Jun 24, 1998 |