Recall Z-1023-2017 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medacta Usa Inc
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or
| Date | Jan 13, 2017 (initiated Dec 7, 2016) |
| Status | Terminated |
| Reason | Damaged packaging, lack of sterility assurance |
| Root cause | Packaging |
| Action | The firm, Medacta International, immediately notified all customers by phone on 12/07/16 and further notified via email on 12/9/16. The firm also issued an "URGENT- Field Safety Notice" dated 7/12/2016 to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to return all units to Medacta International SA and forward the notice to all people and organizations potentially affected. If you have any questions contact Regulatory Affairs Manager at +41 (0) 91 696 60 60. |
| Quantity | 82 units |
| Distribution | Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121115 | M.U.S.T PEDICLE SCREW SYSTEM Medacta International, Jul 18, 2012 |