Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2014 - (Recall #: Z-0977-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 6, 2014

Date Posted: February 19, 2014

Recall Number: Z-0977-2014

Event ID: 67267

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.

Status: Terminated

Product Quantity: 30 units

Code Information:

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

Distribution Pattern:

US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated