Recall record at a glance
| Official record | Z-0304-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Nova Ortho-Med Inc. |
| Report date | Nov 2, 2016 |
| Recall initiation date | Oct 1, 2016 |
| Quantity | 1,380 units |
| Location | Carson, CA, United States |
Official product description
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Why the product was recalled
Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out.
Distribution information
US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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