Orthofix Srl recalls

Orthofix Srl has 34 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 25 Jun 2025. 1 is still ongoing. The most frequent reason is sterility.

Total recalls34since 2018

Last 12 months0reported

Class I00% of total

Ongoing1latest 25 Jun 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 34 100%Class III 0 0%

Why orthofix srl is recalled

Product types

By year

202513%
20193191%
201826%

Ongoing orthofix srl 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 Srl	Sterility	N/A

All orthofix srl recalls, newest first

34 total

Reported	Class	Recall	Company	Reason	Where
25 Jun 2025Device	CLASS II	REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled	Orthofix Srl	Sterility	N/A
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-91647, US Xcaliber Ankle Complete recalled	Orthofix Srl	Device Malfunction	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 1-1100301,Drill BIT Diameter recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92503, Prefix II Diaphyseal recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93504, Elbow Sterile KIT, UDI recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-36501, Radiolucent Wrist Fixator recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref 11007, drill bit diameter 4.8 MM recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-92504, Prefix II Ankle Complete recalled	Orthofix Srl	Sterility	29 states
20 Nov 2019Device	CLASS II	Orthofix Catalogue Number: ref: 99-93502, Lower Limb Diaphyseal recalled	Orthofix Srl	Sterility	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.