The Recall Desk
ModerateFDA (Devices)·Z-0932-2013·Announced 2013-03-20

Spine Smith Partners Recalls Cynch Lordotic T-PLIF Implants Due to Marking Error

Spine Smith Partners LP is recalling three Cynch Lordotic T-PLIF implants distributed in Texas because they were incorrectly laser marked as 23mm instead of 28mm.

What this means for you

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, and the hazard is a labeling error (incorrect laser marking) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Spine Smith Partners LP is recalling three units of the Cynch Lordotic T-PLIF Implant, an intervertebral fusion device with bone graft intended for use with supplemental fixation. The recall affects Part Number 0609-2809-06, Lot 39AQ, which were distributed in Texas.

The recall was initiated because the implants were incorrectly laser marked as 23mm instead of 28mm. This labeling error could potentially lead to the use of an incorrectly sized device during a surgical procedure.

Healthcare providers and patients who have received these specific implants should contact Spine Smith Partners LP for further instructions on how to proceed.

The recalled product

Product
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Affected units
3

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 (2)

  • Part Number: 0609-2809-06
  • Lot: 39AQ

Distribution

Distributed in 1 state: