Recall record at a glance
| Official record | Z-1512-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Howmedica Osteonics Corp. |
| Report date | May 2, 2018 |
| Recall initiation date | Jan 12, 2018 |
| Quantity | 6 units of catalog 5521-B-400 |
| Location | Mahwah, NJ, United States |
Official product description
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Why the product was recalled
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Distribution information
Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
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.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.