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.
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.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send Synthes, Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0669-2018 — Synthes, Inc. Synthes, Inc. recalls LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Use Hello, I own a Synthes, Inc. recalls LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of that is covered by recall Z-0669-2018 from Synthes, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
