FDAAugust 19, 2019device
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within t...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
What to do
FDA enforcement status: Terminated
Brands named
orthopediatrics
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAFRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System2024-07-04
- FDAOrthex Large Bone Shoulder Bolt, model no. AS-172022-09-12
- FDAOrthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN2022-06-29
- FDAOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Numbe...2020-07-06
- FDAOrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.2020-06-05
- FDAOrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.2020-06-05
- FDAOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-00322019-08-19
- FDAModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the sy...2019-08-19
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