Recall Z-2102-2016— Medical Depot Inc.
Class II · Terminated
Class II FDA medical device recall by Medical Depot Inc., initiated 2016-02-17, terminated 2018-06-13. FDA's recall record names no specific 510(k) clearance for this event. Product: EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case. Reason: Tip crutch failure involving the bottom of the metal portion which comes in contact with ground.
- Recalling firm
- Medical Depot Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-17
- Terminated
- 2018-06-13
- Firm location
- Port Washington, NY, United States
Product description
EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
Reason for recall
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Data sourced from openFDA. This site is unofficial and independent of the FDA.