Zimmer Biomet Persona Partial Knee System Size 8 Finishing Guide Recall: Potential Extra
Zimmer Biomet recalls Persona Partial Knee System Size 8 Finishing Guide due to possible extra surgery time or tightness during knee flexion. Affected units have specific item and lot numbers.
Lower-risk recall
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling the Persona Partial Knee System Size 8 Finishing Guide because it may cause longer surgery times or discomfort during knee movement. This affects patients who have had or are scheduled for this specific knee surgery. Read more at govinfonow.com/recall/73469-zimmer-biomet-persona-partial-knee-system-size-8-finishing-guide.
Source Summary by GovInfoNow · govinfonow.com/recall/73469-zimmer-biomet-persona-partial-knee-system-size-8-finishing-guide · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0349-2018
Cite this page
“Zimmer Biomet Persona Partial Knee System Size 8 Finishing Guide Recall: Potential Extra.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73469-zimmer-biomet-persona-partial-knee-system-size-8-finishing-guide. Based on FDA recall #Z-0349-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0349-2018%22&limit=1).
Why it’s dangerous
The finishing guide doesn't properly match the shape of Size 8 knee implants, which could lead to longer surgery or a feeling of tightness when bending the knee. This issue is specific to the Size 8 model and the finishing guide used with it.
Who’s affected
Patients who have received or are scheduled for the Persona Partial Knee System Size 8 surgery are most at risk. This recall applies to those using the specific finishing guide with the listed item and lot numbers.
How to tell if you have this one
Check for the item number 42578100801 or 42578100802 with lot numbers 63518668 or 63518669 on the finishing guide. This recall applies to the Persona Partial Knee System Size 8.
- Brand
Zimmer Biomet- Product
Persona Partial Knee System, Size 8, Finishing Guide- Category
Medical device
What to do — step by step
Check Product Details
Look for item numbers 42578100801 or 42578100802 and lot numbers 63518668 or 63518669 on the finishing guide.
Where it went and when
Where it was distributed
Distributed in 16 states, and outside the U.S.
FDA distribution: “Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Idaho, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, New Mexico, Pennsylvania, South Carolina, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 21 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.
Questions people ask
Is there a risk of serious injury?
The recall states potential for extra surgery time or tightness, but no mention of serious injury. The hazard level is low risk.
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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-0349-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0349-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.