Synthes LCP Drill Sleeve 1.5 Drill Bit 1.1mm Recall: Risk of Surgical Delay
Synthes recalls LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 for possible surgical delay if drill sleeve doesn't attach properly to bone plates.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Synthes is recalling a specific drill sleeve used in bone surgery. If the sleeve doesn't connect to the plate during surgery, it could cause delays or improper bone fixation. Read more at govinfonow.com/recall/73223-synthes-lcp-drill-sleeve-1-5-drill-bit-1-1mm.
Source Summary by GovInfoNow · govinfonow.com/recall/73223-synthes-lcp-drill-sleeve-1-5-drill-bit-1-1mm · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0669-2018
Cite this page
“Synthes LCP Drill Sleeve 1.5 Drill Bit 1.1mm Recall: Risk of Surgical Delay.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73223-synthes-lcp-drill-sleeve-1-5-drill-bit-1-1mm. Based on FDA recall #Z-0669-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0669-2018%22&limit=1).
Why it’s dangerous
The drill sleeve may not attach properly to the bone plate during surgery. If it doesn't connect, surgery could be delayed. If the pilot hole is drilled without the sleeve, the hole might be off-center, causing screws or plates to loosen.
Who’s affected
Orthopedic surgeons and medical professionals using the LCP Modular Mini Fragment System for bone fixation are most at risk. Patients receiving this surgery may be affected if the drill sleeve fails during the procedure.
How to tell if you have this one
Check for Part Number 03.114.001 on the drill sleeve. This product was sold with Lot numbers FT00227, 9972971, H028400, H161606, and H288454.
- Brand
Synthes- Category
Medical device
What to do — step by step
Check Drill Sleeve Attachment
Ensure the drill sleeve connects properly to the bone plate before surgery. If it doesn't, contact your surgeon immediately.
How this recall unfolded
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0669-2018 (August 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0669-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.