PlainRecalls

Orthofix Srl

26 recalls on record · Latest: Jun 25, 2025

Orthofix Srl Recall Insight

Orthofix Srl appears on 26 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.031% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 25, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 26 entries, severity tagging shows 0 critical, 26 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 26 of 26 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (26). The date window on this page runs from Jan 3, 2018 to Jun 25, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 25, 2025

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510895

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93501, PELVIS STERILE KIT, RX ONLY, UDI: (01)18033509859908

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298

FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)18033509859915

FDA Devices Moderate Jun 13, 2018

TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hex…

FDA Devices Moderate Jan 3, 2018

Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNY…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds