Recall Register

Ossur H / F: FDA recalls

FDA enforcement reports name Ossur H / F as the recalling firm in 8 events. The events have 29 product records. The recalls started from 2015 to 2024. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Ossur H / F
InitiatedProduct (first record)TypeClassRecordsStatus
20 Aug 2024Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101DeviceClass II1Ongoing
25 Mar 2024RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentDeviceClass II4Ongoing
26 Dec 2023Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002DeviceClass II1Ongoing
12 May 2023Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020DeviceClass II1Ongoing
14 Mar 2016Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.DeviceClass II6Terminated
24 Feb 2016Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.DeviceClass II14Terminated
4 Mar 2015LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6” ) with female pyramid adapter 153 165mm (6 - 6 1/2”) -Male pyramid…DeviceClass II1Terminated
26 Feb 2015The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the user’s walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the user’s…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Ossur H / F: events for each product type
TypeEvents
Device8
Ossur H / F: events in each class
ClassEvents
Class II8
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
4

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Ossur H / F, by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Ossur H / F: FDA recalls. https://recallregister.com/firm/ossur-h-f/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Ossur H / F have?
Class II: 8 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Ossur H / F?
FDA event 95278, which the firm started on 20 Aug 2024. The first product in the record is: Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
How many FDA recalls of Ossur H / F have the status Ongoing?
4 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.