FDA Medical Device Recalls (openFDA)
ORTHO SOLUTIONS, LTD.: 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.
- Recall number
- Z-0967-2018
- Recalling firm
- ORTHO SOLUTIONS, LTD.
- 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.
- Status
- Terminated
- Initiated
- 2017-10-10
- Posted
- not on file
- Terminated
- 2018-08-31
- 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.
- 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
- 120
- Distribution
- U.S.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K163489"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3008951116
- Firm city
- Maldon
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28