Recall Z-0277-2023— OrthoPediatrics Corp

Name: FDA recall Z-0277-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-12

Class II · Ongoing

Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2022-09-12. It names one FDA 510(k) clearance: K151881. Product: Orthex Large Bone Shoulder Bolt, model no. AS-17. Reason: Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration..

Recalling firm: OrthoPediatrics Corp
Classification: Class II
Status: Ongoing
Initiated: 2022-09-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K151881 — X-Fix Line AdditionsVilex IN Tennessee, Inc.·cleared 2016-03-24

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

Orthex Large Bone Shoulder Bolt, model no. AS-17

Reason for recall

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

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