Orthofix Srl

Complete recall history across all FDA and CPSC categories — 34 total recalls

Orthofix Srl appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (34)

FDA medical device enforcement actions by Orthofix Srl

Date Product Reason Class
Sep 24, 2024 REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Retrospective; Their is the potential that implantable intramedullary lengthe... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COM... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERI... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KI... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, R... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT,... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COAT... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)1803... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COA... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 ... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127M... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPL... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT S... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COAT... As a result of complaint investigations it was determined that batches of dri... Class II
Sep 27, 2018 ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280M... As a result of complaint investigations it was determined that batches of dri... Class II
Jan 30, 2018 TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Size... The firm received complaints regarding the incompatibility and dimensional i... Class II
Jul 5, 2017 Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold indiv... The power drill torque limiter may break during use in surgery application. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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