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.
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, 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.
- Manufacturer
- Spine Smith Partners LP
- Hazard
- 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:
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