Z-1023-2017Class II

Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo...

Name: Z-1023-2017 Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo...
Creator: Medacta Usa Inc
Published: 2016-12-07
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2016-12-07 / Terminated / root cause: packaging

FDA source

Medacta Usa Inc began a recall of 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... on 2016-12-07. FDA classified it as Class II and gives the reason as "Damaged packaging, lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1023-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-07
Posted: 2017-01-13
Terminated: 2017-11-15
Recalling firm: Medacta USA, Inc.
Product: 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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: Damaged packaging, lack of sterility assurance
Root cause tag: packaging
FDA 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 in commerce: 82 units
Distribution: Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Product codes and lots: Lot #s 125212,144216, 148146

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1023-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1023-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13

Product code KWP

K121115Class IIM.u.s.t Pedicle Screw SystemMedacta International / cleared 2012-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)