Reported Mar 21, 2018 · Terminated

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

Ortho Solutions, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ORTHO SOLUTIONS, LTD. · West Station Business Park · Maldon · N/A

Is this the product you have?

23 of 23 products

Products covered by this recall
#Product as published
1SYSTEM 26. Part Numbers: OS900035-NS
2OS900036-NS
3OS900037-NS
4OS900038-NS
5OS900040-NS
6OS900041-NS
7OS900042-NS
8OS900043-NS
9OS900047-NS
10OS900048-NS
11OS900045-NS
12OS900046-NS
13OS900050-NS
14OS900051-NS
15OS900044-NS
16OS900049-NS
17OS900053-NS
18OS900054-NS
19OS900055-NS
20OS900056-NS
Lot codes and dates
  • 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
Amount recalled
120

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ortho Solutions, Ltd. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 31, 2018 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.