Recall Z-1357-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2015-02-23, terminated 2015-09-28. FDA's recall record names no specific 510(k) clearance for this event. Product: RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.. Reason: This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-23
- Terminated
- 2015-09-28
- Firm location
- Warsaw, IN, United States
Product description
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Reason for recall
This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.