Recall Z-2176-2012
Stryker Spine · initiated March 21, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: 48361223, 48361224, 48361225, 48361226, 48361227, 48361228 Lot Code: 084505, 084506, 084507, 084508, 084509, 084510
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: 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.
Details
- Recall number
- Z-2176-2012
- Initiated
- March 21, 2011
- Posted by FDA
- August 9, 2012
- Terminated
- March 21, 2013
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 109 Lots
- Distribution
- Nationwide Distribution including NC, AR, TN, MA, IL, GA, NY, LA, MN, MO, OH, KS, NM, TX, KS,and IN.
- Recalling firm
- Stryker Spine, Allendale, NJ