FDA-Device2023-02-15Class II
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
Wishbone Medical, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of South Carolina.
Affected count
195
Manufactured in
100 Capital Dr, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2023Don't want to check this manually?
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