Orthofix Recalls Lapidus Plates Due to Screw Engagement Failure
Orthofix is voluntarily recalling 156 Lapidus Plates because locking screws failed to properly engage the 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 3/5 (High).
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 source describes a functional defect (screws not engaging) that poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the text.
Plain-English summary
Orthofix, Inc. is conducting a voluntary recall of 156 Lapidus Plates, which are sterile, prescription-only orthopedic devices. The recall involves specific sizes and part numbers from the Rival Reduce Fracture Plating System and Rival View Plating System.
The recall was initiated following a complaint investigation that confirmed the locking screws associated with these plates did not properly engage the plates during surgery. The affected units were distributed to consignees in various U.S. states, including New Jersey, Florida, Pennsylvania, South Carolina, Louisiana, Virginia, Minnesota, Texas, Georgia, the District of Columbia, Nevada, Indiana, California, Michigan, Illinois, Maryland, North Carolina, Ohio, and Oklahoma.
Healthcare providers and patients should check their inventory and records for the specific lot numbers and part numbers listed in the official recall notice. If a patient has received one of these devices, they should contact their healthcare provider for evaluation and appropriate follow-up care.
The recalled product
- Product
- Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e)…
- Manufacturer
- Orthofix, Inc
- Affected units
- 156
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 (11)
- (UDI)/Lot: a) (18056099647588) B1096741
- b) (18056099647595) B1117260
- B1099064
- c) (18056099647625) B1117352
- B1096743
- d) (18056099647632) B1099065 e) (18056099647601) B1117265
- f) (18056099647618) B1098803
- B1116361
- g) 18056099647649) B1200565
- B1116364
- h) (18056099647656) B1123046
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
FDA (Devices) · 2018-06-13
- 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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