| Date Initiated by Firm | July 12, 2004 |
|---|
| Date Posted | August 28, 2004 |
|---|
| Recall Status1 |
Terminated 3 on October 05, 2004 |
| Recall Number | Z-1411-04 |
|---|
| Recall Event ID |
29565 |
| 510(K)Number | K945765 |
|---|
| Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
|
| Product | Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. |
|---|
| Code Information |
Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320. |
| FEI Number |
1825034
|
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw
IN
46582-6989
|
| For Additional Information Contact | Beth Albert
800-348-9500 Ext. 1251 |
|---|
Manufacturer Reason
for Recall | The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified to inspect the devices for the defect via letter dated and faxed 7/12/04. A second letter issued 7/15/04 instructing consignees NOT to inspect the product, but to return all units. |
|---|
| Quantity in Commerce | 79 |
|---|
| Distribution | United States. |
|---|
| 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 = GEI
|
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