Orthohelix Surgical Designs, Inc.
United StatesFDA applicant, unverified
- Devices
- 25
- FDA recalls
- 16
At a glance
Market reach
- United States
- FDA recalls
What Orthohelix Surgical Designs, Inc. makes
Orthohelix Surgical Designs, Inc. manufactures orthopedic fixation systems for bone stabilization, including cannulated screw systems, plating systems, modular foot implants, and staple systems. Their portfolio includes solutions for distal radius fractures, such as the DRLOCK Distal Radius Volar System, and high-torque screw systems like the MAXTORQUE SCREW SYSTEM. The company also produces specialized plating systems, including the MINI MAXLOCK EXTREME PLATING SYSTEM and MAXLOCK EXTREME SYSTEM, designed for extremity and long-bone fixation.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The company’s products are registered with the FDA’s 510(k) clearance system. Orthohelix Surgical Designs, Inc. is headquartered in the United States.
Catalogue
Search and filter all 25 devicesFDA recalls
FDA recall records list 16 recalls initiated by Orthohelix Surgical Designs, Inc., the earliest on 2005-11-01 and the most recent on 2014-09-19. By recorded status: 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity, performance or accuracy 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.
2014
- 19 Sep 2014 Z-0062-2015 Class II Terminated Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
2012
- 30 Oct 2012 Z-0975-2013 Class II Terminated The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
2011
- 22 Aug 2011 Z-0421-2012 Unclassified (pre-2012) Terminated The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
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- 6 Jul 2011 Z-3081-2011 Unclassified (pre-2012) Terminated The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement.
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- 22 Aug 2011 Z-0421-2012 Unclassified (pre-2012) Terminated The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
2010
- 15 Oct 2010 Z-0466-2011 Unclassified (pre-2012) Terminated The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
- 15 Oct 2010 Z-0467-2011 Unclassified (pre-2012) Terminated The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
- 15 Oct 2010 Z-0468-2011 Unclassified (pre-2012) Terminated The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
- 23 Mar 2010 Z-1784-2010 Unclassified (pre-2012) Terminated On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.
- 29 Jan 2010 Z-0026-2013 Class II Terminated The tips of the drivers are breaking while being used to drive the screws into patients.
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- 29 Jan 2010 Z-0027-2013 Class II Terminated The tips of the drivers are breaking while being used to drive the screws into patients.
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Show all 16 recalls
2009
- 16 Oct 2009 Z-1399-2010 Unclassified (pre-2012) Terminated The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument.
Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were
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- 3 Sep 2009 Z-1430-2010 Unclassified (pre-2012) Terminated The epoxy is flaking off the drill bits and countersinks.
- 7 Apr 2009 Z-1250-2010 Unclassified (pre-2012) Terminated A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
- 16 Oct 2009 Z-1399-2010 Unclassified (pre-2012) Terminated The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument.
Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were
2007
- 4 Sep 2007 Z-0136-2008 Unclassified (pre-2012) Terminated Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.
2006
- 3 Aug 2006 Z-0349-2007 Unclassified (pre-2012) Terminated The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
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- 3 Aug 2006 Z-0349-2007 Unclassified (pre-2012) Terminated The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
2005
- 1 Nov 2005 Z-0598-06 Unclassified (pre-2012) Terminated Screwdriver pilot taper tip can break during surgery.
Frequently asked questions
How many devices does Orthohelix Surgical Designs, Inc. have in the registry?
The registry currently lists 25 devices for Orthohelix Surgical Designs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthohelix Surgical Designs, Inc.'s devices?
Among its 25 most recently registered devices, Orthohelix Surgical Designs, Inc. has devices listed in FDA 510(k) (25 devices).
What risk classes do Orthohelix Surgical Designs, Inc.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Orthohelix Surgical Designs, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthohelix Surgical Designs, Inc.?
FDA recall records list 16 recalls initiated by Orthohelix Surgical Designs, Inc., the most recent initiated on 19 Sep 2014. 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 Orthohelix Surgical Designs, Inc. in the registry?
The most recently registered devices listed for Orthohelix Surgical Designs, Inc. include CSS CANNULATED SCREW SYSTEM, MAXLOCK EXTREME SYSTEM, MAXLOCK EXTREME SYSTEM MODEL MXL and MINI MAXLOCK EXTREME PLATING SYSTEM.