FDA (Devices) recall action 64586

Spinal Solutions, LLC recalled 10 products on 2013-06-05

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2013-06-05
Critical: 0
Units: 503

Why these products were recalled

The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
LowFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states
ModerateFDA (Devices)··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…
Category
Distribution
6 states