Medtronic GRAFTON — Class II medical device recall Z-0977-2014
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2014-02-19, distributed in FL, MI, MN, MO, NJ, OH, TX. 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.
| Recall number | Z-0977-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2014-01-06 |
| Classified | 2014-02-12 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-06-24 |
| Distributed | FL, MI, MN, MO, NJ, OH, TX |
| Quantity | 30 units |
| Reason classes | labeling |
| Model numbers | T42100 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0977-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.