5 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting.
FDA Recall
Terminated
·Zimmer Inc.·Product code MNI·January 12, 2009
Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to apply final torque to closure tops of the implant. The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HAO·April 4, 2011
Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011
Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXX·May 20, 2011
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021