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Terminated

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.

FDA Recall Z-1870-2013 · Posted 2013-08-01

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeFZY
Date Initiated2013-04-25
Date Terminated2014-01-09
Product Quantity3

Reason for Recall

Malfunction of slap hammer.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US distributions to states of: KS and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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