| | Class 2 Device Recall |  |
| Date Initiated by Firm | April 28, 2003 |
|---|
| Date Posted | May 29, 2003 |
|---|
| Recall Status1 |
Terminated 3 on November 12, 2003 |
| Recall Number | Z-0901-03 |
|---|
| Recall Event ID |
26267 |
| Product Classification |
Impactor - Product Code HWA
|
| Product | Trident Insert Impactor |
|---|
| Code Information |
Catalog Number: 2111-0000 |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics
300 Commerce Court
Mahwah NJ 07430
|
| For Additional Information Contact | Dominick Cristofolo
201-831-5247 |
|---|
Manufacturer Reason
for Recall | The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt. |
|---|
| Quantity in Commerce | 1758 |
|---|
| Distribution | The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
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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.
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