| Date Initiated by Firm | January 24, 2003 |
|---|
| Date Posted | April 09, 2003 |
|---|
| Recall Status1 |
Terminated 3 on December 01, 2004 |
| Recall Number | Z-0710-03 |
|---|
| Recall Event ID |
25577 |
| 510(K)Number | K964381 |
|---|
| Product Classification |
Prosthesis, Wrist, Carpal Trapezium - Product Code KYI
|
| Product | Finger Joint Implants, Silicone
Models TRL-10 and TRL-20 |
|---|
| Code Information |
TRL-10, Lot 45275002, 13 units shipped TRL-20, Lot 45186001, 30 units shipped |
| FEI Number |
1000519983
|
Recalling Firm/
Manufacturer |
Avanta Orthopaedics, Inc.
9369 Carroll Park Drive Ste A
San Diego CA 92121
|
| For Additional Information Contact | Wally Jansen
763-783-5074 |
|---|
Manufacturer Reason
for Recall | Wrong silicone elastomer used in construction. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete. |
|---|
| Quantity in Commerce | 43 |
|---|
| Distribution | States of CA and UT and to France. |
|---|
| 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 = KYI
|
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