Non-Locking Screw — Class II medical device recall Z-2123-2018
Terminated recall by Orthofix, Inc, reported 2018-06-13, distributed in CA, DC, FL, GA, IL, IN, LA, MD…. Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating Syste
| Recall number | Z-2123-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix, Inc, Lewisville, TX, United States |
| Recall initiated | 2018-04-06 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Terminated | 2021-06-30 |
| Distributed | CA, DC, FL, GA, IL, IN, LA, MD, MI, MN, NC, NJ, NV, OH, OK, PA, SC, TX, VA |
| Quantity | 1,206 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 18056099645959, 18056099645966, 18056099645973, 18056099645980, 18056099645997, 18056099646000, 18056099646017, 18056099646024, 18056099646031, 18056099646048, 18056099646055, 18056099646062, 18056099646079, 18056099646086, 18056099646093, 18056099646109, 18056099646116, 18056099646123, 18056099646130, 18056099646147, 18056099646154 |
| Model numbers | 10MM, 12MM, 14MM, 16MM, 18MM, 20MM, 22MM, 24MM, 26MM, 28MM, 3.2MMX, 30MM, 32MM, 34MM, 36MM, 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM |
Product
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)
Reason for recall
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
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-2123-2018. 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.