OrthoPediatrics Corp FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Orthex Large Bone Shoulder Bolt, model no. AS-17Class IISep 12, 2022Bolt breakage on the head or threaded portion, which may cau	Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may c	Class IIDevices	Sep 12, 2022
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BNClass IIJun 29, 2022Manufacturing variance near transition of tip is increasing	Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The frac	Class IIDevices	Jun 29, 2022