Knee Prosthesis — Class II medical device recall Z-1512-2018
Terminated recall by Howmedica Osteonics Corp., reported 2018-05-02. Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size i
| Recall number | Z-1512-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-05-07 |
| Reason classes | labeling |
| Lot numbers | ATV7IA, ATY40A |
| Model numbers | 5521-B-300, 5521-B-400 |
Product
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
Reason for recall
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1512-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.