Z-0967-2018 Class II Terminated
FDA device recall Z-0967-2018 was initiated by ORTHO SOLUTIONS, LTD. on Oct 10, 2017 and is designated Class II. 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 … The recall status is terminated (terminated Aug 31, 2018). Affected quantity: 120.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Oct 10, 2017
- Termination Date
- Aug 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