Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, I
FDA device recall Z-0977-2014 · posted 2014-02-12 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- 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.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MBP
- Quantity affected
- 30 units
- Distribution
- US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
- Date initiated
- 2014-01-06
- Date posted
- 2014-02-12
- Date terminated
- 2014-06-24
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAFTON DBM (K051188) | Osteotech, Inc. | 2006-01-03 |
| GRAFTON DBM (K051195) | Osteotech, Inc. | 2005-12-16 |