Home / Recalls / ORTHO SOLUTIONS, LTD. / Z-0967-2018

Z-0967-2018 Class II Terminated

Recalled by ORTHO SOLUTIONS, LTD. — Maldon

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
October 10, 2017
Termination Date
August 31, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
120

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.

Distribution Pattern

U.S.

Code Information

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

Other recalls by ORTHO SOLUTIONS, LTD.

  • Z-2780-2017 Class II — Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a (April 19, 2017)
  • Z-2835-2016 Class II — FPS 35mm x 3.5 mm non-locking screw (July 21, 2016)
  • Z-0026-2016 Class II — Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, U (July 14, 2015)