Arthrosurface, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0475-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 9, 2014

Date Posted: December 30, 2015

Recall Number: Z-0475-2016

Event ID: 72695

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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.

Status: Terminated

Product Quantity: 3 units

Code Information:

SN 000242 SN 000244 SN 000246 SN 000247

Distribution Pattern:

US Distribution to the states of : PA, WV and CA.

Voluntary or Mandated:

Voluntary: Firm initiated