Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size… recallZ-1023-2017 · Medacta Usa Inc · initiated Dec 7, 2016
Class II Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Damaged packaging, lack of sterility assurance
FDA root cause category: Packaging
What the company is doing
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.
Recall details
- Recall number
- Z-1023-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 7, 2016
- Posted by the FDA
- Jan 13, 2017
- Recalling firm
- Medacta Usa Inc
- Quantity
- 82 units
- Product code
- KWP
- FDA submissions
- K121115
- Distribution
- Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Product description
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.
Code information (models, lots, serial numbers)
Lot #s 125212,144216, 148146
Other devices under the same FDA submission
20 devices cleared under K121115 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- M.U.S.T. Polyaxial Pedicle Screw 03.50.030Medacta International SA · Appliance, Fixation, Spinal Interlaminal4 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.031Medacta International SA · Orthosis, Spinal Pedicle Fixation4 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.032Medacta International SA · Appliance, Fixation, Spinal Interlaminal3 reports
- M.U.S.T. Rods 03.50.401Medacta International SA · Orthosis, Spinal Pedicle Fixation3 reports
- M.U.S.T. Rods 03.50.403Medacta International SA · Orthosis, Spinal Pedicle Fixation3 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.018Medacta International SA · Orthosis, Spinal Pedicle Fixation2 reports
- M.U.S.T. Rods 03.50.432Medacta International SA · Appliance, Fixation, Spinal Interlaminal2 reports
- M.U.S.T. Rods 03.50.433Medacta International SA · Orthosis, Spinal Pedicle Fixation2 reports
- M.U.S.T. Polyaxial Pedicle Screw 03.50.011Medacta International SA · Appliance, Fixation, Spinal Interlaminal1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.012Medacta International SA · Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.016Medacta International SA · Orthosis, Spinal Pedicle Fixation1 report
- M.U.S.T. Polyaxial Pedicle Screw 03.50.017Medacta International SA · Appliance, Fixation, Spinal Interlaminal1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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