ORTHOPEDIATRICS CORP. devices, product family

Manufacturer

ORTHOPEDIATRICS CORP.(200)

Basic UDI-DI

08411321SSLCJ7

Risk class

Class II·Class IIb (varies)

Legislation

MDR

EMDN category

CORTICAL SCREWS·OSTEOSYNTHESIS SCREW-PLATE SYSTEMS

Market status

200 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 08411321SSLCJ7.

• Z-2843-2016 ·Class II · terminated · 27 Jul 2016
  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.
• Z-2844-2016 ·Class II · terminated · 27 Jul 2016
  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.
• Z-2796-2015 ·Class II · terminated · 28 Jul 2015
  The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
• Z-1941-2013 ·Class II · terminated · 24 Jul 2013
  OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
• Z-0432-2013 ·Class II · terminated · 18 Oct 2012
  Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.
• Z-2057-2012 ·Class II · terminated · 14 Jun 2012
  The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

Recalls matched to the 50 devices listed on this page; other pages of the family can carry others.