The Recall Desk
HighFDA (Devices)·Z-0277-2023·Announced 2023-02-22

Orthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction

OrthoPediatrics has recalled Orthex Large Bone Shoulder Bolts due to breakage risk that may disrupt bone correction and healing. Affected units were distributed in the United States and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an orthopedic implant with a structural defect posing risk of treatment failure and disruption of bone healing. No injuries have been reported, but the potential for serious harm from implant failure in patients undergoing orthopedic correction procedures, combined with a real mechanical hazard, justifies a High severity rating.

Plain-English summary

OrthoPediatrics Corp is recalling the Orthex Large Bone Shoulder Bolt, model AS-17, a component used in orthopedic procedures. The recall affects 1,354 units worldwide, including 594 distributed in the United States.

The bolts may break at the head or threaded portion, causing loss of strut continuity with the fixation frame. This may result in loss of deformity correction and/or disruption of bone regeneration.

The FDA classified this as a Class II recall. No injuries or illnesses have been reported associated with this defect.

The recalled product

Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Manufacturer
OrthoPediatrics Corp
Category
Medical Device — Orthopedic Implant
Hazard
  • bolt-breakage
  • mechanical-failure
  • loss-of-function

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category