CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

Stryker Reliance AL Implant Blocker recalled by Stryker Spine

Stryker Spine is recalling Stryker Reliance AL Implant Blocker (Various sizes) The Slide Implant Blocker is a, distributed nationwide in the US. The recall was initiated on 21 Mar 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510

Quantity recalled109 Lots

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2176-2012
FDA event ID: 62415
Recalling firm: Stryker Spine, Allendale, NJ
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2011
FDA classified: 9 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

21 Mar 2011	Recall initiated by company
9 Aug 2012	Classified by FDA	+507 days
15 Aug 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arkansas Georgia Illinois Indiana Kansas Louisiana Massachusetts Minnesota Missouri North Carolina New Mexico New York Ohio Tennessee Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Stryker Spine

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9 Apr 2025Device	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
9 Apr 2025Device	CLASS II	Monterey AL Implant Inserter recalled by Stryker Spine	Stryker Spine	Other	13 states
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Other Spinal Implants recalls

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30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
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9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide