Pioneer Surgical Technology, Inc.
+1 more
- Pioneer Surgical Technology, Inc., Dba Rti Surgical
United Statesfrom the FDA registration address FDA establishment FEI 1000115331
- Devices
- 69
- Registrations
- FDA
- FDA recalls
- 10
Catalogue
Search and filter all 69 devicesShowing 1-50 of 69
Company details
- FDA FEI number
- 1000115331
- Address
- 375 RIVER PARK CIRCLE, Marquette, MI, 49855
FDA recalls
2014
- 11 Jun 2014 Z-2076-2014 Class II Terminated Lack of Sterility Assurance
2013
- 14 Jun 2013 Z-2616-2014 Class II Terminated The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
2012
- 10 Sep 2012 Z-2573-2014 Class II Terminated Some set screw thread profiles were found not to be within specifications.
2007
- 10 Oct 2007 Z-0291-2008 Unclassified (pre-2012) Terminated The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
2006
- 3 Mar 2006 Z-0872-06 Unclassified (pre-2012) Terminated There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guidewire to advance further into the patient than intended.
2005
- 29 Jul 2005 Z-0020-06 Unclassified (pre-2012) Terminated Screw may be incorrectly etched as to length.
- 29 Jul 2005 Z-0021-06 Unclassified (pre-2012) Terminated Screw may be incorrectly etched as to length.
- 29 Jul 2005 Z-1457-05 Unclassified (pre-2012) Terminated The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
2004
- 20 Jan 2004 Z-0561-04 Unclassified (pre-2012) Terminated Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
2003
- 28 May 2003 Z-0948-03 Unclassified (pre-2012) Terminated Label may bear an incorrect part number [2227-02-02] and size [03.8MM].
Frequently asked questions
How many devices does Pioneer Surgical Technology, Inc. have in the registry?
The registry currently lists 69 devices for Pioneer Surgical Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pioneer Surgical Technology, Inc.'s devices?
Among its 50 most recently registered devices, Pioneer Surgical Technology, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Pioneer Surgical Technology, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Pioneer Surgical Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pioneer Surgical Technology, Inc.?
FDA recall records list 10 recalls initiated by Pioneer Surgical Technology, Inc., the most recent initiated on 11 Jun 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 Pioneer Surgical Technology, Inc. in the registry?
The most recently registered devices listed for Pioneer Surgical Technology, Inc. include PACP, MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM, Tritium Sternal Cable Plate System and PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER).