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.
FDA Recall Z-0967-2018 · Posted None
Advertisement
Recalling FirmORTHO SOLUTIONS, LTD.
Recall StatusTerminated
Product CodeHWC
Date Initiated2017-10-10
Date Terminated2018-08-31
Product Quantity120
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.
Firm Action
Ortho Solutions notified customers of the recall via letter 10/10/2017. The recall notification letter was accompanied by instructions to Distributors and a Product Removal Form.
Root Cause
Process control
Distribution Pattern
U.S.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement