Recall Z-1102-2023— Wishbone Medical, Inc.

Name: FDA recall Z-1102-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-04

Class II · Ongoing

Class II FDA medical device recall by Wishbone Medical, Inc., initiated 2023-01-04. It names one FDA 510(k) clearance: K193368. 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: 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..

Recalling firm: Wishbone Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-04
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K193368 — Smart Correction SystemWishbone Medical, Inc.·cleared 2020-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.