Z-0967-2018Class II

SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS...

Name: Z-0967-2018 SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS...
Creator: Ortho Solutions, Ltd.
Published: 2017-10-10
License: https://open.fda.gov/license/

Ortho Solutions Inc / initiated 2017-10-10 / Terminated / root cause: manufacturing process

FDA source

ORTHO SOLUTIONS, LTD. began a recall of SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS... on 2017-10-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0967-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2018-03-09
Terminated: 2018-08-31
Recalling firm: Ortho Solutions Inc
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.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 120
Distribution: U.S.
Product codes and lots: Lot Numbers: 1088402;1088403;1088404;1088405;1088406;1091608;1091646; 1091648;1091628;1088393;1091658; 1088394;1091586; 1088395;1091598;1088396;1088397;1091623; 1088398;1091618; 1088399;1091596; 1091599; 1088401;1091597; 1088337;1091622;1093232;1088985;1091542; 1088986;1091401;1088987;1091581;1091543; 1088989;1091589;1088990;1091614; 1088991;1091402;1091562

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0967-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0967-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code HWC

K163489Class IIOrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited / cleared 2017-03-08

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)