Recall Z-1102-2023 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Wishbone Medical, Inc.
WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
| Date | Feb 7, 2023 (initiated Jan 4, 2023) |
| Status | Open, Classified |
| Reason | Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction. |
| Root cause | Process design |
| Action | The firm visited the affected consignee on December 30, 2021, to discuss the product issue. |
| Quantity | 195 |
| Distribution | US Nationwide distribution in the state of South Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193368 | Smart Correction System Wishbone Medical, Inc., Sep 18, 2020 |