Serrato 9 — Class II medical device recall Z-2160-2019
Terminated recall by Howmedica Osteonics Corp., reported 2019-08-14, distributed nationwide. Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm l
| Recall number | Z-2160-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2019-06-18 |
| Classified | 2019-08-05 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-05-22 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| UPC / GTIN / UDI-DI | 07613327351576 |
| Lot numbers | B88751 |
| Model numbers | 4826195100, 482619590 |
Product
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Reason for recall
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
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-2160-2019. 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.