FDA recall Z-0669-2018

Synthes, Inc. · Class II · device

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

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

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