Known Identifiers & Locations
FEI Numbers
3001237832
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 (7)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0013-06 |
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0014-06 |
TC-PLUS Tibial Insert 2; 15mm, Model 25309
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0015-06 |
TC-PLUS Tibial Insert UC 4; 11mm, Model 25427
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0016-06 |
TC-PLUS Tibial Insert UC 4; 13mm, Model 25428
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0017-06 |
TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0018-06 |
TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
| Z-0019-06 |
TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
Reason: Did not meet specifications.
|
2005-08-03 |
Terminated
|
View Details
|
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