Recall Z-0977-2014— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-0977-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-06

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2014-01-06, terminated 2014-06-24. It names 2 FDA 510(k) clearances: K051188, K051195. Product: 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. Reason: 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..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Terminated: 2014-06-24
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K051188 — GRAFTON DBMOsteotech, Inc.·cleared 2006-01-03
K051195 — GRAFTON DBMOsteotech, Inc.·cleared 2005-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.