Events

Recall of Device Recall Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes (USA) Products LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72139
  • Event Risk Class
    Class 2
  • Event Number
    Z-2811-2015
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139935
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Plate, cranioplasty, preformed, non-alterable - Product Code GXN
  • Reason
    The synthes cranial flap tube clamp and crimping device for cranial tube clamp had been labeled mr safe although they do not have the testing protocols currently required to designate them as mr safe.
  • Action
    DePuy Synthes sent an URGENT:FIELD SAFETY NOTIFICATION / MEDICAL DEVICE LABELING CORRECTION letter, dated August 31, 2015 to affected customers. The letter identified affected product, problem and actions to be taken. Customers were instructed to: "Update and review the package insert (GP1345-D). " Discard outdated package insert noted in the table above. " Forward this Field Safety Notification to anyone in your facility that needs to be informed, especially personnel that conduct MR testing. " If the package insert has been forwarded to another facility, contact that facility. " Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section by, Fax: 877-884-7821 or Scan/email: Synthes3911@stericycle.com " If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. " Maintain a copy of this notice. For questions call 610-719-5450.

Device

Device Recall Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp
  • Model / Serial
    Part Number 329.315 460.001 460.001.01S 460.002 460.002.01S 460.003 460.003.01S 460.008 460.008.01S 460.009 460.009.01S 460.010 460.010.01S 460.100 460.100.01S 460.107 460.107.01S with Lot Numbers 4146716, 4154144, 4206682, 4206683, 4213557, 4214824, 4216603, 4216604, 4240689, 4240690, 4241741, 4248462, 4249395, 4249396, 4264386, 4278302, 4278304, 4283035, 4283036, 4283037, 4283038, 4283039, 4283040, 4283041, 4285956, 4289103, 4295084, 4295085, 4298044, 4303093, 4326975, 4326979, 4326981, 4329355, 4331263, 4331265, 4331266, 4344659, 4344678, 4378973, 4482201, 4485317, 4488093, 4488094, 4490608, 4490609, 4496716, 4496915, 4496916, 4501971, 4504043, 4508068, 4513458, 4513459, 4513460, 4513461, 4516371, 4519406, 4519407, 4521408, 4525905, 4550062, 4550063, 4550064, 4550065, 4551164, 4551165, 4551166, 4561400, 4561401, 4572176, 4574481, 4580884, 4586704, 4605094, 4661414, 4669482, 4669483, 4675725, 4695343, 4705970, 4723148, 4753792, 4753794, 4777999, 4778000, 4906228, 4906229, 4914498, 4917681, 4934562, 4944809, 4956361, 4956363, 4983255, 4983256, 4983257, 5007806, 5041856, 5041857, 5041858, 5046857, 5046859, 5098159, 5113496, 5113497, 5134868, 5134869, 5143883, 5204105, 5230669, 5234395, 5234396, 5245233, 5245237, 5251710, 5292433, 5308690, 5308733, 5341509, 5370371, 5370375, 5438364, 5452452, 5465222, 5655435, 5667092, 5697537, 5726966, 5726967, 5726968, 5726969, 5726970, 5726971, 5801281, 5801284, 5801285, 5801287, 6036379, 6036381, 6168066, 6188888, 6188890, 6268389, 6268390, 6272370, 6322541, 6364587, 6553805, 6861415, 6983782, 7032568, 7505227, 7640627
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide and internationally, including Canada.
  • Product Description
    Synthes Cranial Flap Tube Clamp and Crimping Device || Product Usage: || The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Manufacturer Address
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA