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Open, Classified

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

FDA Recall Z-1102-2023 · Posted 2023-02-07

Recalling FirmWishbone Medical, Inc.
Recall StatusOpen, Classified
Product CodeKTT
Date Initiated2023-01-04
Product Quantity195

Reason for Recall

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.

Firm Action

The firm visited the affected consignee on December 30, 2021, to discuss the product issue.

Root Cause

Process design

Distribution Pattern

US Nationwide distribution in the state of South Carolina.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193368Smart Correction SystemWishbone Medical, Inc. · 2020-09-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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