Orthofix recalls

Orthofix has 65 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 25 Jun 2025. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls65since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 25 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 65 100%Class III 0 0%

Why orthofix is recalled

Product types

By year

202512%
20193148%
20182437%
201712%
201623%
201523%
201423%
201323%

Ongoing orthofix recalls

1 active

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Device	CLASS II	REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled	Orthofix	Other	N/A

All orthofix recalls, newest first

65 total

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Device	CLASS II	REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled	Orthofix	Other	N/A
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-91647, US Xcaliber Ankle Complete recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1100301,Drill BIT Diameter recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92503, Prefix II Diaphyseal recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93504, Elbow Sterile KIT, UDI recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-36501, Radiolucent Wrist Fixator recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 11007, drill bit diameter 4.8 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92504, Prefix II Ankle Complete recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93502, Lower Limb Diaphyseal recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93502US, Tibia Femur Diaphyseal recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-91647UE, UE Xcaliber Ankle recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1100201,Drill BIT Diameter .4,8 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93503US, Ankle Transfix PIN recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1100101,Drill BIT Diameter 8 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1100201, drill bit diameter 4.8 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93501JP, Pelvis Sterile KIT recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1100301, drill bit diameter 3.2 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1300301,Drill BIT D.3,2 MM L.140 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93501, Pelvis Sterile KIT, RX recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref:99-93503 , Ankle Sterile KIT, UDI recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93502JP, Lower Limb Diaphyseal recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92502, Prefix II Diaphyseal recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 13550, drill bit diameter 2.7 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref recalled by Orthofix Srl	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93601, Galaxy Wrist Sterile KIT recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1100101, drill bit diameter 4.8 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1355001, drill bit diameter 2.7 MM recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-91600UE, UE Xcaliber recalled	Orthofix	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92501, Prefix II Diaphyseal recalled	Orthofix	Device Malfunction	29 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.