Z-0389-2020Class II

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

Name: Z-0389-2020 ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
Creator: Orthofix Srl
Published: 2018-09-27
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2018-09-27 / Terminated / root cause: design

FDA source

Orthofix Srl began a recall of ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719 on 2018-09-27. FDA classified it as Class II and gives the reason as "As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0389-2020
Classification: Class II
Status: Terminated
Initiated: 2018-09-27
Posted: 2019-11-14
Terminated: 2022-02-01
Recalling firm: Orthofix SRL
Product: ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719
Product code: JDW Pin, Fixation, Threaded
Reason for recall: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/01/2018, Orthofix provided distributor, doctors, and hospitals a urgent medical device recall notification via FedEx overnight carrier . The letter asked consignees to take the following actions: 1. Immediately cease any further distribution of the affected devices; 2. Notify hospitals, surgeons and others to whom you may have distributed affected devices that such devices cannot be used and must be returned to Orthofix according to the instructions below; 3. Complete the Acknowledgement Form indicating that you have received this notification. It should be returned by email or fax to the contact details on the attached form. 4. Subsequent Distribution: If your firm has provided or sold the affected products to other users, please provide a list of those users to the undersigned and forward this notification to them to assure prompt action. 5. Product Return Instructions: To return the devices affected by this action, please follow these instructions: A - Check your inventory for the devices affected by this action; B - Complete the attached Acknowledgement Form with the quantity you are returning; C - Contact Orthofix Customer Service at (800) 266-3349 for return instructions and replacement information
Distribution: US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
Product codes and lots: Lot # B1206515, B1206561, B1209206, B1211406, B1212677, B1215964, B1233839

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0374-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0375-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0376-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0377-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0378-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0379-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0380-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0381-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0382-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0383-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0384-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0385-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0386-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0387-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0388-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0389-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0390-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0391-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0392-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0393-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0394-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0395-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0396-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0397-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0398-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0399-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0400-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0401-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0402-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14
Z-0403-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-14

Product code JDW

K955848Class IIOrthofix ModulsystemOrthofix, Inc. / cleared 1996-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)