Reported Feb 19, 2014 · Terminated

Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA,…

Medtronic Sofamor Danek USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Place · Memphis, TN · 38132

Is this the product you have?

  • Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A
  • QTY1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 Orthopaedic - filler, bone void
Lot codes and dates
    • 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
Amount recalled
30 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 24, 2014 · Data as of Sep 19, 6:51 PM UTC

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