Recall Z-0038-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2014-09-03, terminated 2015-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.. Reason: Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-03
- Terminated
- 2015-11-09
- Firm location
- Warsaw, IN, United States
Product description
RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
Reason for recall
Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.