Reported Feb 15, 2023 · Ongoing

WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS…

Wishbone Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wishbone Medical, Inc. · 100 Capital Dr · Warsaw, IN · 46582-6704

Is this the product you have?

  • 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
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberProduct as published
10-702-095115-0Lot 1048176, 1048221 XS, UDI-DI B5621070209511500
10-702-115150-0Lot 1048177 Short, UDI-DI B5621070211515000
10-702-140200Lot 1048178, 1048222, 1048223 Medium, UDI-DI B562107021402000
10-702-190300-0Lot 1048179 Long, UDI-DI B5621070219030000
Lot 1048180
Amount recalled
195

Where it was sold

  • Nationwide
  • SC

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:51 PM UTC

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