| Date Initiated by Firm | November 12, 2002 |
|---|
| Date Posted | December 19, 2002 |
|---|
| Recall Status1 |
Terminated 3 on April 04, 2003 |
| Recall Number | Z-0349-03 |
|---|
| Recall Event ID |
25085 |
| 510(K)Number | K993768 |
|---|
| Product Classification |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
|
| Product | Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis)
Catalog No. 6265-5116 |
|---|
| Code Information |
Lot Codes: 1187701, 1233101, 1187701 |
| FEI Number |
2219689
|
Recalling Firm/
Manufacturer |
Howmedica Osteonics Corp
359 Veterans Blvd
Rutherford NJ 07070
|
| For Additional Information Contact | Thomas Grzeskowiak
201-831-5495 |
|---|
Manufacturer Reason
for Recall | Hip Stem Fractures in the neck area. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002. |
|---|
| Quantity in Commerce | 16 |
|---|
| Distribution | Product was distributed to hospitals and Howmedica Branch reps throughout the US. |
|---|
| 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 = MEH
|
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