FDA Device recall Z-2122-2018
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (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 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (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-2122-2018 |
| 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 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)
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) (18056099646338) B1075104; b) (18056099646345) B1071537, B1083847; c) (18056099646352) B1068544, B10751…(UDI)/Lot: a) (18056099646338) B1075104; b) (18056099646345) B1071537, B1083847; c) (18056099646352) B1068544, B1075103; d) (18056099646369) B1075176; e) (18056099646376) B1075838; f) (18056099646383) B1069676, B1082189; g) (18056099646390) B1071602, B1082231; h) (18056099646406) B1069678, B1084787; i) (18056099646413) B1071672, B1082227, B1071672, B1075052; j) (18056099646420) B1082238; k) (18056099646437) B1084801; l) (18056099646444) B1082214, B1204276; m) (18056099646451) B1215467, B1089836; n) (18056099646468) B1215470, B1089877; o) (18056099646475) B1215466, B1089894; p) (18056099646482) B1195749, B1082234; q) (18056099646499) B1204583, B1089842 |
|---|
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-2122-2018%22
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