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.
- Company
- Stryker Spine
- Recall Initiated
- March 21, 2011
- Posted
- August 9, 2012
- Terminated
- March 21, 2013
- Recall Number
- Z-2176-2012
- Quantity
- 109 Lots
- Firm Location
- Allendale, NJ
Reason for Recall
Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
Distribution
Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.
Lot / Code Info
Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510
Root Cause
Component design/selection
Action Taken
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.