# FDA recall Z-0669-2018

> **Synthes, Inc.** · Class II · device recall initiated 2017-08-07.

## Product

LCP Drill Sleeve 1.5 Drill Bit 1.1mm  Part Number 03.114.001    Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments

## Reason for recall

May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.

## Distribution

Distribution to US, Canada, and Germany.

## Key facts

- **Recall number:** Z-0669-2018
- **Recalling firm:** Synthes, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-07
- **Report date:** 2018-02-28
- **Termination date:** 2018-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Chester, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2018

## Citation

> AI Analytics. FDA recall Z-0669-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0669-2018. Source: US FDA. Licensed CC0.

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