CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
Medacta International SA, M.U.S.T recalled
Medacta Usa is recalling Medacta International SA, M.U.S.T, distributed nationwide in the US. The recall was initiated on 7 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1023-2017
- FDA event ID
- 76034
- Recalling firm
- Medacta Usa, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2016
- FDA classified
- 13 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 7 Dec 2016 | Recall initiated by company | |
| 13 Jan 2017 | Classified by FDA | +37 days |
| 25 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Damaged packaging, lack of sterility assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Questions about this recall
Is Medacta International SA, M.U.S.T recalled?
Yes. Medacta Usa recalled Medacta International SA, M.U.S.T on 7 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1023-2017.
Why was it recalled?
Damaged packaging, lack of sterility assurance
Which lots are affected?
Lot #s 125212,144216, 148146
Where was it sold?
Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medacta Usa
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Short Monobloc Stem Broaches, Size recalled by Medacta Usa | Medacta Usa | Device Malfunction | Nationwide |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H16 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H12 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H18 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Antibackout Lag Cover recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |