Z-1102-2023Class II

WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part...

Name: Z-1102-2023 WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part...
Creator: Wishbone Medical, Inc.
Published: 2023-01-04
License: https://open.fda.gov/license/

Wishbone Medical, Inc. / initiated 2023-01-04 / Open, Classified / root cause: manufacturing process

FDA source

Wishbone Medical, Inc. began a recall of 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... on 2023-01-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1102-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-04
Posted: 2023-02-07
Recalling firm: Wishbone Medical, Inc.
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
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm visited the affected consignee on December 30, 2021, to discuss the product issue.
Quantity in commerce: 195
Distribution: US Nationwide distribution in the state of South Carolina.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1102-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1102-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-07

Product code KTT

K193368Class IISmart Correction SystemWishbone Medical, Inc. / cleared 2020-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)