Medtronic Prestige LP — Class II medical device recall Z-1641-2018
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2018-05-16, distributed nationwide. The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System.
| Recall number | Z-1641-2018 |
|---|---|
| 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 | 2018-03-13 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 231 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00643169752955, 00643169752962, 00643169752979 |
| Lot numbers | ID17J009, ID17K007, ID17K018, ID17L035 |
| Model numbers | 5MM, 6975205, 6975206, 6975207, 6MM, 7MM |
Product
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Reason for recall
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
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-1641-2018. 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.