Recalls / —
—#90859
Product
Synthes Medullary Tubes
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog number 355.01. all lot numbers
Why it was recalled
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.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Synthes USA (HQ), Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- The product was shipped to medical facilities nationwide.
Timeline
- Recall initiated
- 2010-04-01
- Posted by FDA
- 2010-06-16
- Terminated
- 2015-03-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #90859. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.