FDA Device recall Z-2124-2018
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002… by Orthofix, citing 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 wer….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2124-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-06 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthofix |
| Distribution | CA, DC, FL, GA, IL, IN, LA, MD, MI, MN, NC, NJ, NV, OH, OK, PA, SC, TX, VA |
Product
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)
Reason
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.
Identifiers
| code_info | (UDI)/Lot: a) (18056099646505) B1075433; b) (18056099646512) B1075434; c) (18056099646529) B1075844; d) (18056099646…(UDI)/Lot: a) (18056099646505) B1075433; b) (18056099646512) B1075434; c) (18056099646529) B1075844; d) (18056099646536) B1075432; e) (18056099646543) B1075436; f) (18056099646550) B1075826; g) (18056099646567) B1075837; h) (18056099646574) B1084804; i) (18056099646581) B1075835; j) (18056099646598) B1082233; k) (18056099646604) B1204272, B1075829; l) (18056099646611) B1204977, B1082245; m) (18056099646628) B1215471, B1204978, B1082247; n) (18056099646635) B1204979, B1084800; o) (18056099646642) B1204582, B1082248; p) (18056099646659) B1218842, B1204980; q) (18056099646666) B1218840, B1204271, B1089889; r) (18056099646673) B1218843, B1195750, B1083640; s) (18056099646680) B1204981, B1083837; t) (18056099646697) B1204982, B1083846; u) (18056099646703) B1204584, B1083852, B1071600, B1071601 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2124-2018%22
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