Medical device recalls Moderate risk

Wishbone Medical, Inc. recalls WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-…

Recall date
January 4, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1102-2023
FDA classification
Class II
Brand / firm
Wishbone Medical, Inc.
Sold / distributed
US Nationwide distribution in the state of South Carolina.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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