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U.S. Department of Health and Human Services

Class 2 Device Recall LCP Drill Sleeve

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  Class 2 Device Recall LCP Drill Sleeve see related information
Date Initiated by Firm August 07, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on July 25, 2018
Recall Number Z-0669-2018
Recall Event ID 79021
Product Classification Guide, surgical, instrument - Product Code FZX
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
Code Information Lot numbers FT00227 9972971 H028400 H161606 H288454
Recalling Firm/
Manufacturer
Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact
610-719-5000
Manufacturer 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.
FDA Determined
Cause 2
Process design
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: RA-DPYCH-flactionint@ITS.JNJ.com 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.
Quantity in Commerce 567 units
Distribution Distribution to US, Canada, and Germany.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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