Depuy Orthopaedics, Inc.HTOClass I

Reamer

Depuy Orthopaedics, Inc.'s record for this product code

MDR events21,807All time

Recalls1All time

510(k) clearances0All time

Recent MDR events

21,807 adverse event reports on file

Recalls

1 recall events for this product code

TerminatedMar 20, 2013
The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Depuy Orthopaedics, Inc. under this product code.