Recall Z-0475-2016— Arthrosurface, Inc.
Class II · Terminated
Class II FDA medical device recall by Arthrosurface, Inc., initiated 2014-06-09, terminated 2016-02-05. It names one FDA 510(k) clearance: K132496. 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).. Reason: An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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..
- Recalling firm
- Arthrosurface, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-09
- Terminated
- 2016-02-05
- Firm location
- Franklin, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
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An oversight in the implementation of the design change record resulted in outdated components being shipped to customers.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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.