Z-0475-2016Class II

Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number...

Name: Z-0475-2016 Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number...
Creator: Arthrosurface, Inc.
Published: 2014-06-09
License: https://open.fda.gov/license/

Arthrosurface, Inc. / initiated 2014-06-09 / Terminated / root cause: sterility

FDA source

Arthrosurface, Inc. began a recall of Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver... on 2014-06-09. FDA classified it as Class II and gives the reason as "An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0475-2016
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2015-12-23
Terminated: 2016-02-05
Recalling firm: Arthrosurface, Inc.
Product: Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).
Product code: LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Reason for recall: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.
Root cause tag: sterility
FDA root cause: Process change control
Action: The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.
Quantity in commerce: 3 units
Distribution: US Distribution to the states of : PA, WV and CA.
Product codes and lots: SN 000242 SN 000244 SN 000246 SN 000247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0475-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0475-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code LZJ

K132496UnclassifiedArthrosurface ToemotionArthrosurface, Inc. / cleared 2014-02-26

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)