| Date Initiated by Firm |
May 28, 2003 |
| Date Posted |
June 21, 2003 |
| Recall Status1 |
Terminated 3 on September 12, 2003 |
| Recall Number |
Z-0948-03 |
| Recall Event ID |
26405 |
| 510(K)Number |
K990804
|
| Product Classification |
Screw, Fixation, Bone - Product Code HWC
|
| Product |
StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer |
| Code Information |
lot 77091367. |
Recalling Firm/
Manufacturer |
Pioneer Surgical Technology
375 River Park Circle
Marquette MI 49855
|
| For Additional Information Contact |
800-613-6131
|
Manufacturer Reason
for Recall |
Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
|
FDA Determined
Cause 2 |
Other |
| Action |
A recall letter dated 5/28/03 was sent to the sole distributor, asking them to recall from their customers. |
| Quantity in Commerce |
159 |
| Distribution |
Indiana |
| 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 = HWC and Original Applicant = PIONEER SURGICAL TECHNOLOGY
|
