PlainRecalls

Orthofix Srl

Compiled from official public sources by the publisher.

34 recalls on record · Latest: Jun 25, 2025

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Agency notice ledger

Federal filing book Orthofix Srl MID-BOOK · SINGLE-AGENCY

#498 of 14,151 · 34 notices · 0.033% archive

  • BOOK 34 notices
  • RANK #498 of 14,151
  • SHARE 0.033% archive
  • AGENCY FDA Devices (34)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 25, 2025
  • PHOTO Colonia Care Pharmacy

Nearest notice-volume peer: Colonia Care Pharmacy (0 notice gap)

Orthofix Srl accounts for about 0.033% of the 104,423-notice archive on 34 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Orthofix Srl compares to 14,151 recalling firms

Orthofix Srl ranks 498th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Orthofix Srl vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

34 498th of 14151 higher than 13,651 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Orthofix Srl in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Orthofix Srl holds about 0.033% of archive notices alongside 34 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01) 18033509855962
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
FDA Devices Moderate Nov 20, 2019

ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791
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 Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device for stabilization and correction during the normal healing process. The purpose of the TL-HEX System is to provide a solution for deformity correction and keeping the bone segme
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 UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb pri

Orthofix Srl holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (34 here — heavy-book).

Colonia Care Pharmacy 34 Conformis Inc. 34 Ivoclar Vivadent, Inc. 34 Macleods Pharma USA, INC 34 National Fish & Seafood, Inc. 34

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Conformis Inc. 34 Ivoclar Vivadent, Inc. 34 CooperVision, Inc. 33 Custom Healthcare Systems, Inc. 33

Frequently Asked Questions

How many federal recall notices name Orthofix Srl? ▼
PlainRecalls indexes 34 distinct federal recall events naming Orthofix Srl, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Orthofix Srl sit among other recalling firms? ▼
Orthofix Srl ranks #498 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Orthofix Srl's notices? ▼
FDA Devices accounts for 34 of this firm's 34 indexed notices.
What product category dominates Orthofix Srl's filing book? ▼
Filings for Orthofix Srl span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Orthofix Srl: 34 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Orthofix Srl; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026