Prestige LP Streamlined Instruments recallZ-1641-2018 · Medtronic Sofamor Danek USA Inc · initiated Mar 13, 2018

Why it was recalled

The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 13MARCH 2018. The notice requested the following: "Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via fax to 763-367-8134, or via e-mail to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product."

Recall details

Recall number

Z-1641-2018

Status

Terminated

Initiated by the company

Mar 13, 2018

Recalling firm

Medtronic Sofamor Danek USA Inc

Quantity

231 units

Product code

MJO

FDA submissions

P090029

Distribution

US Nationwide Distribution

Product description

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

• Prestige LP Streamlined Instruments 6975205

  Medtronic Sofamor Danek, Inc. · Prosthesis, intervertebral disc
  1 recall1 report
• Prestige LP Streamlined Instruments 6975206

  Medtronic Sofamor Danek, Inc. · Prosthesis, intervertebral disc
  1 recall0 reports
• Prestige LP Streamlined Instruments 6975207

  Medtronic Sofamor Danek, Inc. · Prosthesis, intervertebral disc
  1 recall0 reports

Product lines

• Prestige LP Streamlined InstrumentsMedtronic Sofamor Danek, Inc. · 3 models · 1 reports · 1 recall

Other devices under the same FDA submission

14 devices cleared under P090029 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• PRESTIGE® LP Cervical Disc System 6972660

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  15 reports
• PRESTIGE® LP Cervical Disc System 6972860

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  9 reports
• PRESTIGE LP™ 6972450

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  8 reports
• PRESTIGE® LP Cervical Disc System 6972460

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  6 reports
• PRESTIGE LP™ 6972650

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  5 reports
• PRESTIGE® LP Cervical Disc System 6973060

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  4 reports
• PRESTIGE® LP Cervical Disc System 6972870

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• PRESTIGE® LP Cervical Disc System 6973000

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• PRESTIGE LP™ 6973050

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• PRESTIGE® LP Cervical Disc System 6972670

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• PRESTIGE® LP Cervical Disc System 6972470

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• PRESTIGE® LP Cervical Disc System 6973246

  Medtronic Sofamor Danek, Inc. · PROSTHESIS, INTERVERTEBRAL DISC
  1 report