Recall Z-1950-2009 ยท HRX Arthroscope
Linvatec Corp. dba ConMed Linvatec
PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro B
| 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 | 4,772 |
| 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 |