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 anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
FDA Recall Z-1023-2017 · Posted 2017-01-13
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Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2016-12-07
Date Terminated2017-11-15
Product Quantity82 units
Reason for Recall
Damaged packaging, lack of sterility assurance
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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