Overview of recall records associated with OrthoPediatrics Corp, including dates, categories and classifications where available.
Classification mix: Class II: 8.
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.
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which…
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the…
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the…
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
This page summarizes recall records in which the official source identifies OrthoPediatrics Corp as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
