Home / Recalls / OrthoPediatrics Corp / Z-2844-2016

Z-2844-2016 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
September 28, 2016
Initiation Date
July 27, 2016
Termination Date
March 24, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41

Product Description

3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.

Reason for Recall

OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.

Distribution Pattern

Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None

Code Information

Product Number: 00-1050-3218  Lot Number: NM02346

Other recalls by OrthoPediatrics Corp

  • Z-0277-2023 Class II — Orthex Large Bone Shoulder Bolt, model no. AS-17 (September 12, 2022)
  • Z-1678-2022 Class II — Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN (June 29, 2022)
  • Z-2742-2020 Class II — Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spin (July 6, 2020)
  • Z-2539-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model (June 5, 2020)
  • Z-2538-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model (June 5, 2020)
  • Z-0219-2020 Class II — Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pedia (August 19, 2019)
  • Z-0125-2020 Class II — OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Plat (August 19, 2019)
  • Z-0218-2020 Class II — Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric (August 19, 2019)
  • Z-0597-2018 Class II — Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: P (August 3, 2017)
  • Z-2321-2017 Class II — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-11 (April 24, 2017)