Recall Z-0967-2018— ORTHO SOLUTIONS, LTD.
Class II · Terminated
Class II FDA medical device recall by ORTHO SOLUTIONS, LTD., initiated 2017-10-10, terminated 2018-08-31. It names one FDA 510(k) clearance: K163489. 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: 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..
- Recalling firm
- ORTHO SOLUTIONS, LTD.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-10
- Terminated
- 2018-08-31
- Firm location
- Maldon, United Kingdom
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.