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