Z-0565-2020Class II

INBONE STEM, TIBIAL, TOP, Part Number 200011901

Name: Z-0565-2020 INBONE STEM, TIBIAL, TOP, Part Number 200011901
Creator: Wright Medical Technology, Inc.
Published: 2016-11-08
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2016-11-08 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology, Inc. began a recall of INBONE STEM, TIBIAL, TOP, Part Number 200011901 on 2016-11-08. FDA classified it as Class II and gives the reason as "The firm discovered a lack of adequate documentation confirming sterility on certain products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0565-2020
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Posted: 2019-11-25
Terminated: 2020-11-03
Recalling firm: Wright Medical Technology Inc
Product: INBONE STEM, TIBIAL, TOP, Part Number 200011901
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The firm discovered a lack of adequate documentation confirming sterility on certain products.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall on 11/08/2016 by letter and email to the user level. The firm requested the return of the units.
Quantity in commerce: 65 units
Distribution: US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Product codes and lots: Lot Number 1540433

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0565-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0562-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0563-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0564-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0565-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0566-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0567-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0568-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0569-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0570-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0571-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0572-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25
Z-0573-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-25

Product code HSN

K051023Class IITopez Total Ankle ReplacementTopez Orthopedics, Inc. / cleared 2005-11-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)