Z-0977-2014Class II

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

Name: Z-0977-2014 Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2014-01-06
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2014-01-06 / Terminated / root cause: packaging

FDA source

Medtronic Sofamor Danek USA Inc began a recall of 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... on 2014-01-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0977-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-02-12
Terminated: 2014-06-24
Recalling firm: Medtronic Sofamor Danek USA Inc
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
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Medtronic, sent an "URGENT-V voluntary Market Removal (Recall)" communication letter and questionnaire packet (via FedEx) dated January 3, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the product from normal storage locations; Do not use the product; and as applicable, contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product or call our Global Quality Department at 800-876-3133 ext 3197. In addition, the customers were instructed to disseminate this information to additional personnel within your facility as appropriate. A Medtronic Sales Representative will contact you to facilitate the return of any impacted Set Screw Retaining Drivers you may have in your possession. If you need assistance or if you have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or our Global Quality Department at 800-876-3133 extension 3197.
Quantity in commerce: 30 units
Distribution: US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0977-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-19	2014-02-12

Product code MBP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)