Reamer
Howmedica Osteonics Corp's record for this product code
Recent MDR events
6 adverse event reports on file
- UNIVERSAL DRIVER SHAFTMar 28, 2006Malfunction2249697-2006-00027
- STRAIGHT DRIVER SHAFTDec 16, 2003Malfunction2243265-2003-00109
- UNIVERSAL DRIVER SHAFTAug 21, 2003Malfunction2243265-2003-00066
- ACCOLADE OFFSET RASP HANDLEMar 12, 2003Malfunction2243265-2003-00013
- 11-13MM STARTER/SIZER AWLMay 14, 2001Malfunction2219689-2001-00069
- OSTEONICS SCORPIO 7/9 NOTCH PUNCHApr 9, 1999Injury2243265-1999-00016
Recalls
4 recall events for this product code
- TerminatedMay 17, 2012
A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.
View FDA record ↗ - TerminatedFeb 17, 2010
Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
View FDA record ↗ - TerminatedFeb 17, 2010
Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
View FDA record ↗ - TerminatedAug 27, 2008
The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Howmedica Osteonics Corp under this product code.