CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
Persona Partial Knee System, Size 8, Finishing Guide recalled
Zimmer Biomet is recalling Persona Partial Knee System, Size 8, Finishing Guide, distributed nationwide in the US. The recall was initiated on 5 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0349-2018
- FDA event ID
- 78725
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jul 2017
- FDA classified
- 14 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 5 Jul 2017 | Recall initiated by company | |
| 14 Jan 2018 | Classified by FDA | +193 days |
| 24 Jan 2018 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Persona Partial Knee System, Size 8, Finishing Guide
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoIdahoIllinoisIndianaMassachusettsMarylandMichiganNew JerseyNew MexicoPennsylvaniaSouth CarolinaTexasWashingtonWisconsin
Stores named: Walmart
Questions about this recall
Is Persona Partial Knee System, Size 8, Finishing Guide recalled?
Yes. Zimmer Biomet recalled Persona Partial Knee System, Size 8, Finishing Guide on 5 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0349-2018.
Why was it recalled?
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.
Which lots are affected?
Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
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