Z-1870-2013Class II

S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial...

Name: Z-1870-2013 S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial...
Creator: SpineFrontier, Inc.
Published: 2013-04-25
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2013-04-25 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of... on 2013-04-25. FDA classified it as Class II and gives the reason as "Malfunction of slap hammer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1870-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2013-08-01
Terminated: 2014-01-09
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Product code: FZY Hammer, Surgical
Reason for recall: Malfunction of slap hammer.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, SpineFrontier, sent an advisory notice entitled "URGENT April 25, 2013 S-LIFT Slap Hammer Removal" dated April 25, 2013 via email to its customers. The notice described the product, problem and action to be taken. The notice requested the removal of all distributed SLIFT Slap Hammer with listed lot number. The customers were instructed to complete and return the URGENT S-LIFT Slap Hammer Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email to [email protected]. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.
Quantity in commerce: 3
Distribution: US distributions to states of: KS and TX.
Product codes and lots: Lot: 56H26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1870-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1870-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code FZY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)