| Date Initiated by Firm | October 24, 2016 |
|---|
| Date Posted | December 01, 2016 |
|---|
| Recall Status1 |
Terminated 3 on April 11, 2017 |
| Recall Number | Z-0690-2017 |
|---|
| Recall Event ID |
75627 |
| 510(K)Number | K141484 |
|---|
| Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
| Product | FMsealer Open Shears. Model FM3001 |
|---|
| Code Information |
Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091 |
| FEI Number |
3005350457
|
Recalling Firm/
Manufacturer |
Domain Surgical, Inc.
1370 S 2100 E
Salt Lake City UT 84108-2244
|
| For Additional Information Contact | Holley Moss
801-924-4950 |
|---|
Manufacturer Reason
for Recall | Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc. |
|---|
| Quantity in Commerce | 70 units US; 175 units OUS |
|---|
| Distribution | Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees. |
|---|
| 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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