FDAClass IIFebruary 15, 2023

WishBone Medical Smart Correction Dual Joint Express recall

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…

Why was WishBone Medical Smart Correction Dual Joint Express 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

XXS, Part No. 10-702-080095-0 UDI-DI B5621070208009500 Lot 1048176, 1048221 XS, Part No. 10-702-095115-0 UDI-DI B5621070209511500 Lot 1048177 Short, Part No. 10-702-115150-0 UDI-DI B5621070211515000 Lot 1048178, 1048222, 1048223 Medium, Part No. 10-702-140200 UDI-DI B562107021402000 Lot 1048179 Long, Part No. 10-702-190300-0 UDI-DI B5621070219030000 Lot 1048180

Product
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…
Recalling firm
Wishbone Medical, Inc.
Quantity
195
Distribution
US Nationwide distribution in the state of South Carolina.
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls