Z-1932-2013Class II

T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled...

Name: Z-1932-2013 T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled...
Creator: SpineFrontier, Inc.
Published: 2012-08-29
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-08-29 / Terminated / root cause: manufacturing process

FDA source

SpineFrontier, Inc. began a recall of T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone... on 2012-08-29. FDA classified it as Class II and gives the reason as "During an operation the strike plate of a T-Handle loosened and separated from the T-Handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1932-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-29
Posted: 2013-08-08
Terminated: 2013-10-18
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On August 29, 2011, The Supply Chain Team was notified of the recall via email. They were informed that all handles are being pulled from the field. This resulted in the return of all T-Handles to SpineFrontier. Further questions please call (978) 232-3990.
Quantity in commerce: 11
Distribution: US Distribution including the states of MA, NV and TX.
Product codes and lots: Lot Numbers: 1335201A, 1446101A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1932-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1932-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-08

Product code MDM

K092815Class IIS-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc. / cleared 2010-06-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)