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Terminated

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

FDA Recall Z-0669-2018 · Posted None

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeFZX
Date Initiated2017-08-07
Date Terminated2018-07-25
Product Quantity567 units

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.

Firm Action

In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: [email protected] or call 610-719-5450. In the event that you have product requiring use: Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.

Root Cause

Process design

Distribution Pattern

Distribution to US, Canada, and Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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