Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of...
FDA Device Recall #Z-1292-2016 — Class II — February 24, 2016
Recall Summary
| Recall Number | Z-1292-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 24, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ossur H / F |
| Location | Reykjavik, N/A |
| Product Type | Devices |
| Quantity | 34 |
Product Description
Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
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
Distribution Pattern
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
Lot / Code Information
Item No: B-242500002 B-242500003 B-242500004 B-242500005
Other Recalls from Ossur H / F
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0006-2025 | Class II | Miami J Select Collar, Catalog: MJS-101; Miami ... | Aug 20, 2024 |
| Z-1789-2024 | Class II | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, ... | Mar 25, 2024 |
| Z-1787-2024 | Class II | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, Ext... | Mar 25, 2024 |
| Z-1788-2024 | Class II | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, Ext... | Mar 25, 2024 |
| Z-1790-2024 | Class II | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, ... | Mar 25, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.