Abbott Spine, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
- FDA recalls
- 16
At a glance
Market reach
- United States
- FDA recalls
What Abbott Spine, Inc. makes
Abbott Spine, Inc. manufactures spinal fixation and stabilization devices, including polyaxial pedicle screws, dynamic cervical plates, and modular spinal systems. Their products include the Pathfinder System for pedicle screws, the Ardis spacer for interbody support, and the Nex-Link spinal fixation system with variable crosslinks, rod-to-rod connectors, and offset components. Additional offerings include the Sequoia spinal system with transverse connectors, the Spinnaker system for spinal alignment, and the Universal Clamp System for modular attachment. The portfolio also covers the NexLink Oct System and open polyaxial screws for flexible spinal stabilization.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device authorization requirements. Abbott Spine, Inc. is headquartered in the United States.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 16 recalls initiated by Abbott Spine, Inc., the earliest on 2005-11-02 and the most recent on 2008-04-17. By recorded status: 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 17 Apr 2008 Z-1784-2008 Unclassified (pre-2012) Terminated Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca
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- 24 Mar 2008 Z-1592-2008 Unclassified (pre-2012) Terminated Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
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- 24 Mar 2008 Z-1593-2008 Unclassified (pre-2012) Terminated Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.
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- 13 Feb 2008 Z-1479-2008 Unclassified (pre-2012) Terminated Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
- 17 Apr 2008 Z-1784-2008 Unclassified (pre-2012) Terminated Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca
2007
- 19 Dec 2007 Z-0880-2008 Unclassified (pre-2012) Terminated Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
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- 18 Jul 2007 Z-0004-2008 Unclassified (pre-2012) Terminated Tip of PathFinder surgical instrument broke during procedure.
- 18 Jul 2007 Z-0005-2008 Unclassified (pre-2012) Terminated Tip of PathFinder surgical instrument broke during procedure.
- 19 Dec 2007 Z-0880-2008 Unclassified (pre-2012) Terminated Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.
2006
- 7 Nov 2006 Z-0354-2007 Unclassified (pre-2012) Terminated Tip of devices may dislodge while in use during surgery.
- 7 Nov 2006 Z-0355-2007 Unclassified (pre-2012) Terminated Tip of devices may dislodge while in use during surgery.
- 15 May 2006 Z-1154-06 Unclassified (pre-2012) Terminated Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
Show all 16 recalls
2005
- 14 Nov 2005 Z-0292-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
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- 14 Nov 2005 Z-0293-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
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- 14 Nov 2005 Z-0294-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
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- 14 Nov 2005 Z-0295-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
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- 14 Nov 2005 Z-0296-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
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- 2 Nov 2005 Z-0502-06 Unclassified (pre-2012) Terminated Implants were manufactured without radiographic markers.
- 14 Nov 2005 Z-0292-06 Unclassified (pre-2012) Terminated Modification to labeling for surgical implant.
Frequently asked questions
How many devices does Abbott Spine, Inc. have in the registry?
The registry currently lists 13 devices for Abbott Spine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Spine, Inc.'s devices?
Among its 13 most recently registered devices, Abbott Spine, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Abbott Spine, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Abbott Spine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Spine, Inc.?
FDA recall records list 16 recalls initiated by Abbott Spine, Inc., the most recent initiated on 17 Apr 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Abbott Spine, Inc. in the registry?
The most recently registered devices listed for Abbott Spine, Inc. include PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS, ARDIS SPACER, NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX and ABBOTT SPINE, INC. SPINNAKER SYSTEM.