| Date Initiated by Firm | March 24, 2006 |
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| Date Posted | April 26, 2006 |
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| Recall Status1 |
Terminated 3 on December 12, 2007 |
| Recall Number | Z-0798-06 |
|---|
| Recall Event ID |
35033 |
| 510(K)Number | K020480 |
|---|
| Product Classification |
Retention Device, Suture - Product Code KGS
|
| Product | FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair.
Product Number: 7209399 |
|---|
| Code Information |
Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
|
| For Additional Information Contact | Jason Bilobram
978-474-6332 |
|---|
Manufacturer Reason
for Recall | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor. |
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FDA Determined
Cause 2 | Other |
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| Action | Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product. |
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| Quantity in Commerce | 1800 units |
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| Distribution | Nationwide
Foreign: Austria, Germany, France, Italy, Australia |
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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.
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| 510(K) Database | 510(K)s with Product Code = KGS
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