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Recall Observatory FDA recall evidence

Device 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).

Z-0475-2016

June 09, 2014

Class II

Product summary

Firm
Arthrosurface, Inc.
Event
Event 72695
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0475-2016

Official wording

Reason: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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

Code information: SN 000242 SN 000244 SN 000246 SN 000247

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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