Known Identifiers & Locations
FEI Numbers
3003604053
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 (5)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0040-2011 |
Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Reason: Endofemoral Aimer tip may separate due to failure of the soldered joint
|
2010-04-29 |
Terminated
|
View Details
|
| Z-0041-2011 |
Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Catalog Number: 72201714
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Reason: Endofemoral Aimer tip may separate due to failure of the soldered joint
|
2010-04-29 |
Terminated
|
View Details
|
| Z-0042-2011 |
Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Catalog Number: 72201715
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Reason: Endofemoral Aimer tip may separate due to failure of the soldered joint
|
2010-04-29 |
Terminated
|
View Details
|
| Z-0043-2011 |
Smith & Nephew Aimer Endofemoral 6mm Offset (Green)
Catalog Number: 72201716
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Reason: Endofemoral Aimer tip may separate due to failure of the soldered joint
|
2010-04-29 |
Terminated
|
View Details
|
| Z-0044-2011 |
Smith & Nephew Aimer Endofemoral 7mm Offset (Gold)
Catalog Number: 72201717
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Reason: Endofemoral Aimer tip may separate due to failure of the soldered joint
|
2010-04-29 |
Terminated
|
View Details
|
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