SYSTEM 26 — Class II medical device recall Z-0967-2018
Terminated recall by ORTHO SOLUTIONS, LTD., reported 2018-03-21. Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot
| Recall number | Z-0967-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO SOLUTIONS, LTD., Maldon, United Kingdom |
| Recall initiated | 2017-10-10 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-08-31 |
| Quantity | 120 |
| Lot numbers | 1088337, 1088393, 1088394, 1088395, 1088396, 1088397, 1088398, 1088399, 1088401, 1088402, 1088403, 1088404, 1088405, 1088406, 1088985, 1088986, 1088987, 1088989, 1088990, 1088991, 1091401, 1091402, 1091542, 1091543, 1091562, 1091581, 1091586, 1091589, 1091596, 1091597, 1091598, 1091599, 1091608, 1091614, 1091618, 1091622, 1091623, 1091628, 1091646, 1091648 and 2 more |
| Model numbers | OS900035-NS |
Product
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.
Reason for recall
Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
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-0967-2018. 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.