PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 15, 2023 Initiated: January 4, 2023 #Z-1102-2023

Product Description

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

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.

Details

Recalling Firm
Wishbone Medical, Inc.
Units Affected
195
Distribution
US Nationwide distribution in the state of South Carolina.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Wishbone Medical, Inc.. Units affected: 195.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1102-2023.