Recall Z-0669-2018 ยท FZX Guide, Surgical, Instrument
Synthes, Inc.
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
| Date | Aug 7, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 po |
| Quantity | 567 units |
| Distribution | Distribution to US, Canada, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.