CLASS II Device recall · Reported 13 Jun 2018 · FDA Enforcement Report
Non-Locking Screw, D, Sterile recalled by Orthofix
Orthofix is recalling Non-Locking Screw, D, Sterile, distributed in 19 states. The recall was initiated on 6 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2121-2018
- FDA event ID
- 79819
- Recalling firm
- Orthofix, Lewisville, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2018
- FDA classified
- 7 Jun 2018
- Reported
- 13 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 Apr 2018 | Recall initiated by company | |
| 7 Jun 2018 | Classified by FDA | +62 days |
| 13 Jun 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f) D 2.7MM X 18MM (002-D-27018); g) D 2.7MM X 20MM (002-D-27020); h) D 2.7MM X 22MM (002-D-27022); i) D 2.7MM X 24MM (002-D-27024); j) D 2.7MM X 26MM (002-D-27026); k) D 2.7MM X 28MM (002-D-27028); l) D 2.7MM X 30MM (002-D-27030); m) D 2.7MM X 32MM (002-D-27032); n) D 2.7MM X 34MM (002-D-27034); o) D 2.7MM X 36MM (002-D-27036); p) D 2.7MM X 38MM (002-D-27038); q) D 2.7MM X 40MM (002-D-27040)
Where it was distributed
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
CaliforniaDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaLouisianaMarylandMichiganMinnesotaNorth CarolinaNew JerseyNevadaOhioOklahomaPennsylvaniaSouth CarolinaTexasVirginia
Questions about this recall
Is Non-Locking Screw, D, Sterile recalled?
Yes. Orthofix recalled Non-Locking Screw, D, Sterile on 6 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-2121-2018.
Why was it recalled?
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.
Which lots are affected?
(UDI)/Lot: a) (8056099645782) B1075108; b) (18056099645799) B1075105 c) (18056099645805) B1071598, B1075178, B1075178; d) 18056099645812) B1069675, B1075431, B1075431; e) (18056099645829) B1071545, B1075435; f) (18056099645836) B1071540, B1075839; g) (18056099645843) B1068567, B1075827, B1075827; h) (18056099645850) B1082175, B1082175; i) (18056099645867) B1082237, B1068549, B1082237; j) (18056099645874) B1075060, B1082182; k) (18056099645881) B1068574, B1082236; l) (18056099645898) B1204990, B1071594, B1082232; m) (18056099645904) B1204993, B1071543, B1082222; n) (18056099645911) B1071542, B1195742, B1083645; o) (18056099645928) B1071539, B1083644, B1195708, B1083644; p) (18056099645935) B1204989, B1071541, B1089895; q) (18056099645942) B1069679, B1195752, B1069679, B1082235
Where was it sold?
U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orthofix
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rival Reduce Kit Plates, Sterile recalled by Orthofix | Orthofix | Sterility | 19 states |
| Device | CLASS II | Locking Screw, Sterile recalled by Orthofix | Orthofix | Sterility | 19 states |
| Device | CLASS II | TN Plate, Sterile recalled by Orthofix | Orthofix | Sterility | 19 states |
| Device | CLASS II | Straight Plate, Sterile recalled by Orthofix | Orthofix | Sterility | 19 states |
| Device | CLASS II | Box Plate, Sterile recalled by Orthofix | Orthofix | Sterility | 19 states |
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