FDA Device recall Z-2123-2018
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 (…
- FDA Device
- Class II
- terminated
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of 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 (… 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-2123-2018 |
| 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
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
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) (18056099645959) B1082246; b) (18056099645966) B1075836; c) (18056099645973) B1084806; d) (18056099645…(UDI)/Lot: a) (18056099645959) B1082246; b) (18056099645966) B1075836; c) (18056099645973) B1084806; d) (18056099645980) B1089892; e) (18056099645997) B1075845; f) (18056099646000) B1084797; g) (18056099646017) B1084792; h) (18056099646024) B1084799; i) (18056099646031) B1083858; j) (18056099646048) B1083859; k) (18056099646055) B1089891, B1195735; l) (18056099646062) B1195736, B1089882; m)(18056099646079) B1204992, B1083850; n) (18056099646086) B1083848, B1195699; o) (18056099646093) B1195732, B1089896; p) (18056099646109) B1204991, B1083642; q) (18056099646116) B1195739, B1083851; r) (18056099646123) B1204988, B1083637; s) (18056099646130) B1195733, B1089898; t) (18056099646147) B1195744, B1083838; u) (18056099646154) B1195730, B1071599, B1083853 |
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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-2123-2018%22
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