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Matortho FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Nov 3, 2022
No warning letters matched by name

Inspections 3

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 1 Latest Nov 17, 2014

Matortho has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Matortho" is on file.

What these totals cover: FDA records filed under the name "Matortho".

Latest inspection: Nov 3, 2022 · NAI
Latest 510(k): Nov 17, 2014

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	1	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Matortho's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Matortho: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

3 inspections from Oct 22, 2015 to Nov 3, 2022.

Date	Site	Product	Classification	FEI
Nov 3, 2022	Leatherhead, United Kingdom	Devices	No Action Indicated (NAI)	3008985661
Mar 5, 2020	Leatherhead, United Kingdom	Devices	Voluntary Action Indicated (VAI)	3008985661
Oct 22, 2015	Leatherhead, United Kingdom	Devices	Voluntary Action Indicated (VAI)	3008985661

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008985661	Leatherhead, United Kingdom	3	Nov 3, 2022

Recent 510(k) clearances

1 510(k) clearance on Nov 17, 2014.

K-Number	Device	Date
K140222	SAIPH KNEE SYSTEM	Nov 17, 2014

Matortho and the FDA: common questions

Has Matortho received an FDA warning letter?

No FDA warning letter addressed to the name "Matortho" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Matortho received an FDA Form 483?

FDA has not published a Form 483 for "Matortho" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Matortho?

The most recent FDA inspection on file ended Nov 3, 2022 at Leatherhead, United Kingdom and was classified NAI. FDA has 3 inspections of Matortho on file.

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