Z-0932-2013Class II

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

Name: Z-0932-2013 Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental...
Creator: Spine Smith Partners LP
Published: 2012-08-24
License: https://open.fda.gov/license/

Spine Smith Partners L.P. / initiated 2012-08-24 / Terminated / root cause: labeling and UDI

FDA source

Spine Smith Partners LP began a recall of Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation on 2012-08-24. FDA classified it as Class II and gives the reason as "Implants were incorrectly laser marked as 23mm instead of 28mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0932-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-24
Posted: 2013-03-10
Terminated: 2013-05-17
Recalling firm: Spine Smith Partners L.P.
Product: Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Implants were incorrectly laser marked as 23mm instead of 28mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.
Quantity in commerce: 3 units
Distribution: Distributed in Texas.
Product codes and lots: Part Number: 0609-2809-06, Lot: 39AQ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0932-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0932-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-10

Product code MAX

K101085Class IISpinesmith Cynch Spinal SystemSpine Smith Partners L.P. / cleared 2010-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)