| Date Initiated by Firm | December 04, 2006 |
|---|
| Date Posted | February 08, 2007 |
|---|
| Recall Status1 |
Terminated 3 on February 21, 2007 |
| Recall Number | Z-0399-2007 |
|---|
| Recall Event ID |
37024 |
| 510(K)Number | K051146 |
|---|
| Product Classification |
knee prosthesis component - Product Code JWH
|
| Product | Triathlon X3 CR Tibial Bearing Insert
for knee prosthesis
Size #2 - 11MM
Ref # 5530-G-211
2011-09
Howmedica Osteonics Corp. |
|---|
| Code Information |
Ref. No. 5530-G-211 Lot code G9XF6 LAF974 |
| FEI Number |
3003070421
|
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah
NJ
07430-2002
|
| For Additional Information Contact | Larry Ross
201-831-5972 |
|---|
Manufacturer Reason
for Recall | A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt. |
|---|
| Quantity in Commerce | 23 units |
|---|
| Distribution | Nationwide and Canada. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = JWH
|
|---|
