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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Event Detail

Event ID 65033
Product Type Devices
Status Ongoing
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern US distributions to states of: KS and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot: 56H26 Class II Malfunction of slap hammer. 3 Z-1870-2013