| Date Initiated by Firm |
April 01, 2010 |
| Date Posted |
June 16, 2010 |
| Recall Status1 |
Terminated 3 on March 25, 2015 |
| Recall Number |
Z-1804-2010 |
| Recall Event ID |
55438 |
| Product Classification |
Orthopedic manual surgical instrument, Medullary Tubes - Product Code LXH
|
| Product |
Synthes Medullary Tubes |
| Code Information |
Catalog number 355.01. all lot numbers |
Recalling Firm/
Manufacturer |
Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
|
| For Additional Information Contact |
Customer Support
800-620-7025
|
Manufacturer Reason
for Recall |
After repeated sterilizations product may become discolored and break including while in the medullary canal. Synthes has determined that the Medullary Tube will be a single use item that is to be discarded after one sterilization cycle.
|
FDA Determined
Cause 2 |
Other |
| Action |
The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter.
Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant. |
| Quantity in Commerce |
18,505 tubes |
| Distribution |
The product was shipped to medical facilities nationwide. |
| 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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