Known Identifiers & Locations
FEI Numbers
3003070421
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-0011-06 |
Allocraft TLIF Bone Inserter.
Reason: Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
|
2005-04-04 |
Terminated
|
View Details
|
| Z-0014-2011 |
Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600.
Made in Ireland;
Howmedica Osteonics;
325 Corporate Drive,
Mahwah, NJ 07430
Intended for primary or secondary reconstruction of the distal femur.
Reason: Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.
|
2006-10-05 |
Terminated
|
View Details
|
Profile Disclaimer
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