Extremity Medical, Llc HTOClass I

Reamer

Extremity Medical, Llc's record for this product code

MDR events1All time

Recalls1All time

510(k) clearances0All time

Recent MDR events

1 adverse event reports on file

XMCPDec 13, 2018
Malfunction3007289093-2018-00033

Recalls

1 recall events for this product code

TerminatedNov 26, 2012
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Extremity Medical, Llc under this product code.