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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Reliance AL Implant Blocker

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 Class 2 Device Recall Stryker Reliance AL Implant Blockersee related information
Date Initiated by FirmMarch 21, 2011
Date PostedAugust 09, 2012
Recall Status1 Terminated 3 on March 21, 2013
Recall NumberZ-2176-2012
Recall Event ID 62415
Product Classification Instrument, manual, surgical, general use - Product Code MDM
ProductStryker 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.
Code Information Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactMs. Michelle Barry
201-760-8287
Manufacturer Reason
for Recall		Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
FDA Determined
Cause 2		Component design/selection
ActionStryker 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 Commerce109 Lots
DistributionNationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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