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Recall Observatory FDA recall evidence

Device 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 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0

Z-1102-2023

January 04, 2023

Class II

Product summary

Firm
Wishbone Medical, Inc.
Event
Event 91526
Status
Ongoing
Classification
Class II
Quantity
195
Official record key
device-enforcement:Z-1102-2023

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide distribution in the state of South Carolina.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.