The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2053-2015·Announced 2015-07-15

RTI Surgical Recalls Songer Spinal Cable System Due to Labeling Error

RTI Surgical is recalling 25 units of the Songer Spinal Cable System because the box end label incorrectly identifies the material as Titanium instead of Stainless Steel.

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: The recall is classified as FDA Class II due to a minor labeling error regarding material composition, which fits the rubric criteria for moderate severity involving labeling issues without reported injuries.

Plain-English summary

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) is recalling 25 units of the Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The recall is due to a labeling error where the box end label incorrectly identifies the implant material as Titanium rather than Stainless Steel.

The affected lot number is PL 193368, with a manufacture date of 09/09/2014 and an expiration date of 09/09/2019. The product was distributed in Massachusetts. The DePuy Spine Cable System is an implantable device utilized in spinal procedures where monofilament wire is indicated.

Healthcare providers and patients should verify the material composition of any implanted devices from this specific lot. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
Manufacturer
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Category
Medical Device — Spinal Implant
Hazard
Affected units
25

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)

  • Lot Number: PL 193368 Manufacture Date: 09/09/2014 Expiration Date: 09/09/2019

Distribution

Distributed in 1 state:

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