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
This recall has been terminated (originally issued August 7, 2017).
- Company
- Synthes, Inc.
- Recall Initiated
- August 7, 2017
- Terminated
- July 25, 2018
- Recall Number
- Z-0669-2018
- Quantity
- 567 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot numbers FT00227 9972971 H028400 H161606 H288454
Root Cause
Process design
Action Taken
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.