CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
Unloader XT recalled by Ossur H / F
Ossur H / F is recalling Unloader XT, distributed in 48 states. The recall was initiated on 24 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1294-2016
- FDA event ID
- 73380
- Recalling firm
- Ossur H / F, Reykjavik, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2016
- FDA classified
- 31 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 24 Feb 2016 | Recall initiated by company | |
| 31 Mar 2016 | Classified by FDA | +36 days |
| 6 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Where it was distributed
U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Unloader XT recalled?
Yes. Ossur H / F recalled Unloader XT on 24 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1294-2016.
Why was it recalled?
Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
Which lots are affected?
Item No: B-102500010 B-102500020 B-102600010 B-102600020
Where was it sold?
U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ossur H / F
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Miami J Select Collar recalled by Ossur H / F | Ossur H / F | Lead & Heavy Metals | 39 states |
| Device | CLASS II | RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |