Recalls / —
—#160465
Product
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
- FDA product code
- OAR — Injector, Vertebroplasty (Does Not Contain Cement)
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575
Why it was recalled
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
Root cause (FDA determination)
Process control
Action the firm took
Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following: "If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel within your facility as appropriate, and maintain a copy of this notice in your records. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product."
Recalling firm
- Firm
- Medtronic Sofamor Danek USA Inc
- Address
- 1800 Pyramid Pl, Memphis, Tennessee 38132-1703
Distribution
- Distribution pattern
- US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Timeline
- Recall initiated
- 2017-12-06
- Terminated
- 2019-11-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160465. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.