Reported Mar 21, 2018 · Terminated
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS;…
Ortho Solutions, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ORTHO SOLUTIONS, LTD. · West Station Business Park · Maldon · N/A
Is this the product you have?
23 of 23 products
| # | Product as published |
|---|---|
| 1 | SYSTEM 26. Part Numbers: OS900035-NS |
| 2 | OS900036-NS |
| 3 | OS900037-NS |
| 4 | OS900038-NS |
| 5 | OS900040-NS |
| 6 | OS900041-NS |
| 7 | OS900042-NS |
| 8 | OS900043-NS |
| 9 | OS900047-NS |
| 10 | OS900048-NS |
| 11 | OS900045-NS |
| 12 | OS900046-NS |
| 13 | OS900050-NS |
| 14 | OS900051-NS |
| 15 | OS900044-NS |
| 16 | OS900049-NS |
| 17 | OS900053-NS |
| 18 | OS900054-NS |
| 19 | OS900055-NS |
| 20 | OS900056-NS |
- Lot codes and dates
- Lot Numbers
108840210884031088404108840510884061091608109164610916481091628108839310916581088394109158610883951091598108839610883971091623108839810916181088399109159610915991088401109159710883371091622109323210889851091542108898610914011088987109158110915431088989109158910889901091614108899110914021091562
- Lot Numbers
- Amount recalled
- 120
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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