Manufacturer

Spinal Solutions, LLC

11 recalls in our database name Spinal Solutions, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 1
Most recent: 2013-06-05

Of the 11 recalls from Spinal Solutions, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

ModerateFDA (Devices)·Z-1413-2013·2013-06-05
Spinal Solutions Recalls 50 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 55 units of 50 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1415-2013·2013-06-05
Spinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions
Spinal Solutions, LLC is recalling 56 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has de
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1416-2013·2013-06-05
Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
Spinal Solutions is recalling 35 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1418-2013·2013-06-05
Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions
Spinal Solutions is recalling loaner bins and sterilization trays for spinal implants because directions for use and surgical techniques were not provided to every physician.
Product
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The comp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1410-2013·2013-06-05
Spinal Solutions Recalls 50 mm Screws Due to Missing Surgical Instructions
Spinal Solutions is recalling 52 units of 50 mm screws because directions for use and surgical techniques were not provided to every physician.
Product
50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1409-2013·2013-06-05
Spinal Solutions Recalls 45 mm Screws Due to Missing Instructions
Spinal Solutions is recalling 24 units of 45 mm screws because directions for use and surgical techniques were not provided to every physician.
Product
45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1414-2013·2013-06-05
Spinal Solutions Recalls 60 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 72 units of 60 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1411-2013·2013-06-05
Spinal Solutions Recalls Set Screws Due to Missing Surgical Instructions
Spinal Solutions is recalling 106 Set Screws (Item #BG3010) because directions for use and surgical techniques were not provided to every physician.
Product
Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1417-2013·2013-06-05
Spinal Solutions Recalls Copperhead IBFD Loaner Bins Due to Missing Instructions
Spinal Solutions is recalling Copperhead IBFD loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Product
Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a va
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1412-2013·2013-06-05
Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions
Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.
Product
40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1157-2013·2013-05-01
Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing
Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.
Product
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10d
Category
Medical Device
Distribution
Distributed nationwide