Events

Recall of Device Recall Stryker AccuLIF PL Cages

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Howmedica Osteonics Corp..

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
    74931
  • Event Risk Class
    Class 2
  • Event Number
    Z-2788-2016
  • Event Initiated Date
    2016-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148849
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Since stryker acquired the acculif product in march of 2014, there have been product inquires (pis) related to the pl implant confirming to have a reduction of height > 1 mm. the current occurrence rate for reported post-operative reduction of cage height (> 1mm) of acculif pl expandable cages is approximately 0.47% and has demonstrated a slight upward trend since september 2015.
  • Action
    Stryker Spine sent an "Urgent Recall Letter and Product Accountability Form" dated July 26, 2016 to all affected customers. For patients who have had an AccuLIF Posterior Lumbar (PL) Expandable Interbody implant, Stryker Spine is recommending routine clinical and radiographic post-operated evaluation. Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed. Customers with questions should call 201-749-8389 or 201-749-8346.

Device

Device Recall Stryker AccuLIF PL Cages
  • Model / Serial
    Catalog #400010 Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    NationwideDistribution
  • Product Description
    AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion
  • Manufacturer
    Howmedica Osteonics Corp.

Manufacturer

Howmedica Osteonics Corp.
  • Manufacturer Address
    Howmedica Osteonics Corp., 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA