Blackstone Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 45
- FDA recalls
- 11
At a glance
Market reach
- United States
- FDA recalls
What Blackstone Medical, Inc. makes
Blackstone Medical, Inc. manufactures spinal fixation and reconstruction devices, including systems for laminoplasty, posterior and anterior cervical plating, vertebral body replacement, and modular pedicle screw modifications. Their portfolio includes polyether ether ketone (PEEK) implants, titanium mesh, angled end rings, and axial connectors for spinal stabilization. Additional products cover lateral offset modifications, pillar spacers, and lordotic lateral spacers for spinal alignment.
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. Blackstone Medical, Inc. is headquartered in the United States.
Catalogue
Search and filter all 45 devicesFDA recalls
FDA recall records list 11 recalls initiated by Blackstone Medical, Inc., the earliest on 2005-12-23 and the most recent on 2010-04-21. By recorded status: 11 terminated. The reasons filed fall into these groups: 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.
2010
- 21 Apr 2010 Z-1611-2010 Unclassified (pre-2012) Terminated Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
- 21 Apr 2010 Z-1612-2010 Unclassified (pre-2012) Terminated Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
- 21 Apr 2010 Z-1613-2010 Unclassified (pre-2012) Terminated Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
- 21 Apr 2010 Z-1614-2010 Unclassified (pre-2012) Terminated Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
- 21 Apr 2010 Z-1615-2010 Unclassified (pre-2012) Terminated Certain lots of the non-cannulated Modular Bone Taps used with the Firebird Spinal Fixation Systems may contain a manufacturing non conformance resulting in the taps creating a single lead screw thread rather than the required dual lead screw thread.
- 15 Mar 2010 Z-1653-2010 Unclassified (pre-2012) Terminated The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
- 2 Feb 2010 Z-1144-2010 Unclassified (pre-2012) Terminated The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.
2009
- 21 May 2009 Z-1655-2009 Unclassified (pre-2012) Terminated Product marketed without an approved 510(k)
2007
- 15 May 2007 Z-0363-2008 Unclassified (pre-2012) Terminated Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a comprom
2006
- 8 May 2006 Z-0478-2008 Unclassified (pre-2012) Terminated Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
Show all 11 recalls
2005
- 23 Dec 2005 Z-0716-06 Unclassified (pre-2012) Terminated Pedicle Screw may disengage in post op period requiring intervention
Frequently asked questions
How many devices does Blackstone Medical, Inc. have in the registry?
The registry currently lists 45 devices for Blackstone Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blackstone Medical, Inc.'s devices?
Among its 45 most recently registered devices, Blackstone Medical, Inc. has devices listed in FDA 510(k) (45 devices).
What risk classes do Blackstone Medical, Inc.'s devices fall under?
Among its 45 most recently registered devices, the classes recorded for Blackstone Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Blackstone Medical, Inc.?
FDA recall records list 11 recalls initiated by Blackstone Medical, Inc., the most recent initiated on 2010-04-21. 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 Blackstone Medical, Inc. in the registry?
The most recently registered devices listed for Blackstone Medical, Inc. include BLAKSTONE LAMINOPLASTY FIXATION SYSTEM, BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS, BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM and MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM.