Known Identifiers & Locations
FEI Numbers
1818910
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0013-2011 |
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.
Reason: Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).
|
2010-06-15 |
Terminated
|
View Details
|
| Z-0038-2015 |
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.
|
2014-09-03 |
Terminated
|
View Details
|
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