Z-2176-2012Class II

Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument...

Name: Z-2176-2012 Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument...
Creator: Stryker Spine
Published: 2011-03-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-03-21 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to... on 2011-03-21. FDA classified it as Class II and gives the reason as "Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2176-2012
Classification: Class II
Status: Terminated
Initiated: 2011-03-21
Posted: 2012-08-09
Terminated: 2013-03-21
Recalling firm: Howmedica Osteonics Corp
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.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
Root cause tag: design
FDA root cause: Component design/selection
Action: Stryker sent an Urgent Product Recall letters/return response forms dated April 5, 2012, via FedEX to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital location to identify the product. Reconcile any SLIDE Implant Blockers with catalog and lot numbers referenced above. Retrieve and return the affected product using the enclosed pre-paid mailing label to Stryker Spine 59 Route 17 South, Allendale, New Jersey, 07401. For questions customers were instructed to call 201-760-8298.
Quantity in commerce: 109 Lots
Distribution: Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.
Product codes and lots: Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2176-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2176-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-09

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)