Synthes, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0669-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 7, 2017

Date Posted: February 28, 2018

Recall Number: Z-0669-2018

Event ID: 79021

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.

Status: Terminated

Product Quantity: 567 units

Code Information:

Lot numbers FT00227 9972971 H028400 H161606 H288454

Distribution Pattern:

Distribution to US, Canada, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated