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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · OrthoPediatrics Corp
See all →- HighExternal Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
FDA (Devices) · 2022-09-14
- SevereOrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk
FDA (Devices) · 2020-08-05
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
- ModerateOrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06
Similar recalls
- ModerateOrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06
- ModerateOrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06
- HighOSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts
FDA (Devices) · 2023-02-08
- HighAllen Medical Systems Recalls Traction Boots Due to Assembly Defect
FDA (Devices) · 2013-03-27
- HighOrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk
FDA (Devices) · 2019-10-23
- HighBiomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk
FDA (Devices) · 2014-06-25