Date Initiated by Firm |
January 06, 2010 |
Date Posted |
February 24, 2010 |
Recall Status1 |
Terminated 3 on October 06, 2010 |
Recall Number |
Z-0825-2010 |
Recall Event ID |
54238 |
510(K)Number |
K021458
|
Product Classification |
Plate, fixation, bone - Product Code HRS
|
Product |
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Synthes USA (HQ), Inc. 1302 Wrights Ln E West Chester PA 19380-3417
|
For Additional Information Contact |
Customer Service 800-479-6329
|
Manufacturer Reason for Recall |
There is the potential for the bender/cutter attachment to continue heating after release of the power
button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
|
FDA Determined Cause 2 |
Other |
Action |
An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant. |
Quantity in Commerce |
187 units |
Distribution |
Nationwide Distribution. |
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 = HRS and Original Applicant = SYNTHES (USA)
|