Ossur Americas recalls
Every recall we track for Ossur Americas — 12 in all, from 2018–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Ossur Americas peaked in 2018 (8); 12 since 2017.
All FDA recall records for Ossur Americas since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 8 | 0 | 8 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 2 | 0 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Ossur Americas product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Ossur Americas recalls
5 shown- Use cautionMedical device
Ossur Americas recalls OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF
Ossur recalls Power Knee models PKA10003 and PKA01001L/T with battery that may dislodge. Affected users should contact Ossur for details.
OssurAug 29, 2022 - Use cautionMedical device
Ossur Americas recalls OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Ossur recalls children's and adolescent foot and ankle prostheses (VARIFLEX SUBA JUNIOR) due to cracks that can break under sudden twisting or bending forces.
OssurMay 30, 2022 - Lower riskMedical device
Ossur Americas recalls Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Ossur recalls Miami J Select Collar (MJS-101) and Set (MJSR-101) due to updated instructions for use. No safety hazard exists; this is a routine update to improve user guidance.
OssurNov 9, 2021 - Use cautionMedical device
Ossur Americas recalls OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF:
Ossur recalls Miami J Select Collar collars with lot numbers MX180425 to MX200306 due to racks deforming under load, potentially allowing more neck movement. Affected users should contact Ossur for details.
OssurJun 1, 2021 - Lower riskMedical device
Ossur Americas recalls Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in
Ossur recalls specific skull pins due to a label error listing ceramic tip instead of titanium. Affected products were sold from June 2009 to December 2018. Correct label should state titanium pin.
OssurJun 21, 2018
Ossur Americas recall questions
How many recalls has Ossur Americas had?
12 recalls from Ossur Americas are on record with U.S. safety agencies, from 2018–2022.
What is the most recent Ossur Americas recall?
Ossur Americas recalls OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF, dated Aug 29, 2022. Every Ossur Americas recall is listed on this page, newest first.
What should I do if I have a recalled Ossur Americas product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Ossur Americas recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.