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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100

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  Class 2 Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100 see related information
Date Initiated by Firm January 06, 2014
Date Posted February 12, 2014
Recall Status1 Terminated 3 on June 24, 2014
Recall Number Z-0977-2014
Recall Event ID 67267
510(K)Number K051188  K051195  
Product Classification Filler, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
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
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
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis TN 38132
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBP and Original Applicant = OSTEOTECH, INC.
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