Recall Z-2176-2012— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2011-03-21, terminated 2013-03-21. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-03-21
- Terminated
- 2013-03-21
- Firm location
- Allendale, NJ, United States
Product description
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.
Reason for recall
Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.