Recalls / —
—#148604
Product
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K150496
- Affected lot / code info
- P239175
Why it was recalled
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Root cause (FDA determination)
Employee error
Action the firm took
On 07/18/2016, the firm initiated the correction by verbally notifying (by visit and telephone) three of four (3 of 4) implanting surgeons; the fourth implanting surgeon was verbally notified on 07/25/2016. The firm followed with a letter to all four (4) surgeons on 07/28/2016. Medtronic recommended that the condition of the patients receiving the subject part be assessed for any indications of premature failure during normal post-operative follow-up visits.
Recalling firm
- Firm
- Medtronic Sofamor Danek USA Inc
- Address
- 1800 Pyramid Pl, Memphis, Tennessee 38132-1703
Distribution
- Distribution pattern
- AR, MN,MA
Timeline
- Recall initiated
- 2016-07-18
- Terminated
- 2016-11-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #148604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.