FDAClass IIMarch 21, 2018

System 26 recall

SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS…

Why was System 26 recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS…
Recalling firm
ORTHO SOLUTIONS, LTD.
Quantity
120
Distribution
U.S.
Recall date
March 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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