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Recall Observatory FDA recall evidence

Device product

Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final position.

Z-2176-2012

March 21, 2011

Class II

Product summary

Firm
Stryker Spine
Event
Event 62415
Status
Terminated
Classification
Class II
Quantity
109 Lots
Official record key
device-enforcement:Z-2176-2012

Official wording

Reason: Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.

Code information: Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510

Distribution pattern: Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.