Recall Z-1951-2009 ยท HRX Arthroscope
Linvatec Corp. dba ConMed Linvatec
PowerProMax PRO5100M Battery Single Trigger, PowerProMax PRO5200M Battery Two Trigger, PowerProMax PRO5250M Battery Two-Trigger Standard, PowerProMax PRO5300M Battery Oscillator, PowerProMax PRO5400M Battery Reciprocator, and PowerProMax PRO6200 Battery Single Trigger. 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 I 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 | 5,553 (4,235 INITIAL AND 1,318 EXPANDED) |
| 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 |