Medacta International SA — Class II medical device recall Z-1023-2017
Terminated recall by Medacta Usa Inc, reported 2017-01-25, distributed nationwide. Damaged packaging, lack of sterility assurance
| Recall number | Z-1023-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2016-12-07 |
| Classified | 2017-01-13 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-11-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CH, ES, IT |
| Quantity | 82 units |
| Reason classes | sterility |
| Lot numbers | 125212, 144216, 148146 |
| Model numbers | 03.50.433 |
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.
Reason for recall
Damaged packaging, lack of sterility assurance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1023-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.