FDA recall Z-1102-2023

Wishbone Medical, Inc. · Class II · 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

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.

Distribution

US Nationwide distribution in the state of South Carolina.

Key facts

Status: Ongoing
Initiation date: 2023-01-04
Report date: 2023-02-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2023