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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Recall Number Z-1681-2014
Classification Class II
Code Info Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.
Product Distributed Qty 3
Reason For Recall Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Event Detail

Event Id 68006
Product Type Devices
Status Ongoing
Recalling Firm Synthes, Inc.
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of FL, NJ and MN.