Recalls / —
—#117143
Product
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
- FDA product code
- HRS — Plate, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K011335
- Affected lot / code info
- Part Number 241.000.011, lot number S2004
Why it was recalled
The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.
Recalling firm
- Firm
- Synthes USA HQ, Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- Nationwide distribution.
Timeline
- Recall initiated
- 2013-02-22
- Posted by FDA
- 2013-06-19
- Terminated
- 2015-05-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #117143. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.