OrthoPediatrics Corp: 16 recalls on record

Recalls filed with 1 agency: FDA (16).

First recall on record: August 1, 2012. Most recent: August 5, 2020.

Risk classification: Class II: 16

Most recent recalls

DateAgencyProduct
August 5, 2020FDAOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System …Z-2742-2020
July 15, 2020FDAOrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10…Z-2539-2020
November 6, 2019FDAModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nail…Z-0219-2020
June 14, 2017FDAResponse BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) …Z-2321-2017
September 30, 2015FDA3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903…Z-2796-2015
September 10, 2014FDAACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm…Z-2560-2014
February 12, 2014FDA3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-262…Z-0934-2014
January 1, 2014FDAOrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reco…Z-0579-2014
November 20, 2013FDA3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Fem…Z-0276-2014
August 21, 2013FDA3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to …Z-1941-2013
June 19, 2013FDA90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The Orth…Z-1536-2013
June 19, 2013FDA90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The Orth…Z-1535-2013
June 19, 2013FDA90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The Orth…Z-1534-2013
November 28, 2012FDA4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteo…Z-0432-2013
November 14, 2012FDATrochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails…Z-0207-2013
August 1, 2012FDAOrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 H…Z-2057-2012

Questions about this company

How many recalls does OrthoPediatrics Corp have?
Recalert has 16 U.S. recalls on record for OrthoPediatrics Corp, published between August 1, 2012 and August 5, 2020.
What was the most recent OrthoPediatrics Corp recall?
FDA recall Z-2742-2020, published August 5, 2020: Orthopedics 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 pa…
Which agencies have handled OrthoPediatrics Corp recalls?
OrthoPediatrics Corp appears as the recalling firm in recalls from: FDA (16).

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