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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
Recall Number Z-0977-2014
Classification Class II
Code Info A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147
Product Distributed Qty 30 units
Reason For Recall Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.

Event Detail

Event Id 67267
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Sofamor Danek USA Inc
City Memphis
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
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