Howmedica AccuL: Insertion Handle Recall - Risk of Implant Pivot During Surgery
Howmedica recalls AccuLIF TL Insertion Handle model 800804 with lot numbers 160010 and 170003 due to potential implant pivot during surgery. Affected patients should contact Howmedica for details.
Use caution until it’s fixed
When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.
Contact the company
What happened, in plain English
Howmedica is recalling its AccuLIF TL Insertion Handle (model 800804) because it may allow the implant to pivot when the lever is locked, which could cause improper placement during spinal surgery. This recall affects surgeons and patients who have received the specific model and lot numbers. Read more at govinfonow.com/recall/73045-howmedica-accul-insertion-handle-recall-risk-of-implant-pivot-during.
Source Summary by GovInfoNow · govinfonow.com/recall/73045-howmedica-accul-insertion-handle-recall-risk-of-implant-pivot-during · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0810-2018
Cite this page
“Howmedica AccuL: Insertion Handle Recall - Risk of Implant Pivot During Surgery.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73045-howmedica-accul-insertion-handle-recall-risk-of-implant-pivot-during. Based on FDA recall #Z-0810-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2018%22&limit=1).
Why it’s dangerous
When the lever is locked, the implant might pivot instead of staying rigidly connected. This could lead to improper placement of the spinal implant during surgery, potentially causing complications.
Who’s affected
Surgeons who use the AccuLIF TL Insertion Handle during spinal fusion procedures are most at risk. Patients who have received the recalled model and lot numbers may need to contact Howmedica for further instructions.
How to tell if you have this one
Check for model number 800804 and lot numbers 160010 or 170003 on the handle. The product was sold for spinal surgery procedures.
- Brand
Howmedica- Category
Medical device
What to do — step by step
Check Product Details
Identify the model number (800804) and lot numbers (160010, 170003) on the handle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 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-0810-2018 (September 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0810-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.