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
A16707-098A16707-099A16707-100A16707-101A16707-102A16707-103A16707-104A16707-105A16707-106A16707-107A16707-108A16707-109A16707-110A16707-111A16707-112A16707-113A16707-114A16707-115A16707-116A16707-117A16707-118A16707-119A16707-120A16707-121A16707-122A16707-123A16707-124A16707-125A16707-142and 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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