FDA Recall
Terminated
Synthes Medullary Tubes
Recall: Z-1804-2010
·
Initiated April 1, 2010
Recall
- Recall Number
- Z-1804-2010
- Event Number
- 55438
- Firm
- Synthes USA (HQ), Inc.
- FEI Number
- 3005180112
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 1, 2010
- Posted
- June 16, 2010
- Terminated
- March 25, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
Synthes Medullary Tubes
Reason
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.
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.
Distribution
The product was shipped to medical facilities nationwide.
Quantity
18,505 tubes