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Recall Observatory FDA recall evidence

Device product

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

Z-0932-2013

August 24, 2012

Class II

Product summary

Firm
Spine Smith Partners LP
Event
Event 62993
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-0932-2013

Official wording

Reason: Implants were incorrectly laser marked as 23mm instead of 28mm.

Code information: Part Number: 0609-2809-06, Lot: 39AQ

Distribution pattern: Distributed in Texas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Implants were incorrectly laser marked as 23mm instead of 28mm.