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Ortoma AB recalls

Ortoma AB has 1 recall on record with the FDA and USDA, the earliest in 2025 and the latest reported on 1 Oct 2025. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls1since 2025

Last 12 months0reported

Class I00% of total

Ongoing1latest 1 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 1 100%Class III 0 0%

Why ortoma ab is recalled

Device Malfunction1100%

Product types

Hip & Knee Implants1100%

By year

20251100%

Ongoing ortoma ab recalls

1 active

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight recalled	Ortoma AB	Device Malfunction	Nationwide

All ortoma ab recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight recalled	Ortoma AB	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.