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Recall Observatory FDA recall evidence

Device 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.

Z-1870-2013

April 25, 2013

Class II

Product summary

Firm
SpineFrontier, Inc.
Event
Event 65033
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-1870-2013

Official wording

Reason: Malfunction of slap hammer.

Code information: Lot: 56H26

Distribution pattern: US distributions to states of: KS and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Malfunction of slap hammer.

Field note

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