Orthofix Locking Screws Recalled for Failure to Engage Plates
Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional failure of a medical device during surgery. While no specific injuries are reported in the source text, the risk of harm from improper plate engagement during orthopedic surgery justifies a High severity rating.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of locking screws used in the Rival Reduce Fracture Plating System and the Rival View Plating System. The recall involves 870 units of sterile, prescription-only locking screws in various sizes, ranging from 2.0mm x 8mm to 2.0mm x 30mm.
The recall was initiated following a complaint investigation that confirmed the locking screws did not properly engage the plates during surgery. This defect could compromise the stability of the orthopedic fixation during the procedure.
The affected products were distributed to consignees in New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, Washington D.C., Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma. Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI codes listed in the official recall notice and contact Orthofix, Inc. for further instructions.
The recalled product
- Product
- Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0
- Manufacturer
- Orthofix, Inc
- Affected units
- 870
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- (UDI)/Lot: a) (18056099646161)B1204974
- B1089899
- B1201171
- b) (18056099646178) B1195696
- B1204268
- B1083839
- c) (18056099646185) B1215486
- B1201172
- B1204281
- B1083845
- d) (18056099646192) B1215489
- B1204975
- B1083855
- B1201173
- e) (18056099646208) B1215482
- B1204585
- B1195748
- B1089887
- f) (18056099646215) B1215488
- B1204559
Distribution
Part of a larger recall action
This product is one of 20 recalled by Orthofix, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Orthofix, Inc
See all →- HighOrthofix Non-Locking Screws Recalled Due to Failure to Engage Plates
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure
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- HighOrthofix Recalls Non-Locking Screws Due to Failure to Engage Plates
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- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
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- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
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