FDA recall record · openFDA

Wishbone Medical, Inc.

2 FDA recalls on record (2023–2024) — 2 device. 2 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to th 1

The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the pack 1

Recalls

WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. Class II 2024-04-05 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Numb Class II 2023-01-04

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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