| Date Initiated by Firm | January 23, 2003 |
|---|
| Date Posted | May 21, 2003 |
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| Recall Status1 |
Terminated 3 on December 01, 2004 |
| Recall Number | Z-0853-03 |
|---|
| Recall Event ID |
25640 |
| 510(K)Number | K973121 |
|---|
| Product Classification |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
|
| Product | Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft. |
|---|
| Code Information |
Catalog No.: 66402127 Lot: LXZY |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
|
| For Additional Information Contact | Thomas Grzeskowiak
201-831-5495 |
|---|
Manufacturer Reason
for Recall | The device is demonstrating early wear and delamination. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx. |
|---|
| Quantity in Commerce | 1 |
|---|
| Distribution | Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA. |
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| 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
|
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