FDAClass IIMarch 20, 2013

Cynch Lordotic T-PLlF Implant. Intervertebral fusion recall

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

Why was Cynch Lordotic T-PLlF Implant. Intervertebral fusion recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Recalling firm
Spine Smith Partners LP
Quantity
3 units
Distribution
Distributed in Texas.
Recall date
March 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls