The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1413-2013·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall involving a documentation issue (missing directions for use) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Spinal Solutions, LLC is recalling 55 units of 50 mm Rods (Item #BG1650). The recall was initiated because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

The company distributes spinal fixation devices in loaner bins or on consignment. The affected units were distributed nationwide in the states of Mississippi, Texas, Nevada, California, Maryland, and Wisconsin.

Physicians and healthcare facilities should stop using the affected 50 mm Rods and contact Spinal Solutions for further instructions regarding the missing documentation.

The recalled product

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…
Manufacturer
Spinal Solutions, LLC
Category
Medical Device — Spinal Fixation
Hazard
Affected units
55

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Item #BG1650

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Spinal Solutions, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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