# FDA recall Z-1641-2018

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2018-03-13.

## 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.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1641-2018
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-13
- **Report date:** 2018-05-16
- **Termination date:** 2020-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1641-2018

## Citation

> AI Analytics. FDA recall Z-1641-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1641-2018. Source: US FDA. Licensed CC0.

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