Orthofix Locking Screws Recalled for Failure to Engage Plates
Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural failure of a medical device during surgery, which poses a significant risk of injury or compromised treatment efficacy.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of 1,302 units of Locking Screws, Sterile, Rx Only, associated with the Rival Reduce Fracture Plating System and Rival View Plating System. The affected products are manufactured by Orthofix, Inc. and labeled with ORTHOFIX S.r.r. Italy. The recall covers specific sizes ranging from 2.7mm x 8mm to 2.7mm x 40mm, identified by various part numbers and lot codes.
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. The affected units 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 patients should check their inventory and records for the specific part numbers and lot codes listed in the official recall notice. If you have used or possess these specific locking screws, contact Orthofix, Inc. for instructions on how to return or replace the product. Do not use the recalled screws for surgical procedures until further notice.
The recalled product
- 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…
- Manufacturer
- Orthofix, Inc
- Affected units
- 1,302
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) (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
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
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- SevereOrthofix Recalls MTP Plates Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
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