CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Persona Stemmed Tibial Provisional Size H Right recalled
Zimmer Biomet is recalling Persona Stemmed Tibial Provisional Size H Right, distributed nationwide in the US. The recall was initiated on 7 Aug 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-1806-2018
- FDA event ID
- 79991
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Aug 2017
- FDA classified
- 11 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 7 Aug 2017 | Recall initiated by company | |
| 11 May 2018 | Classified by FDA | +277 days |
| 23 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
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 Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Why was it recalled?
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Which lots are affected?
Lot 63683139, UDI (01)00889024246942(10)63683139; Lot 63613121, UDI (01)00889024246942(10)63613121
Where was it sold?
Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 79991| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Persona Cemented Tibial SZ PLT Size H Left recalled by Zimmer Biomet | Zimmer Biomet | Device Malfunction | Nationwide | |
| CLASS II | Persona Stemmed Tibial Provisional Size H Left recalled by Zimmer Biomet | Zimmer Biomet | Device Malfunction | Nationwide | |
| CLASS II | Persona Cemented Tibial SZ PLT Size H Right recalled by Zimmer Biomet | Zimmer Biomet | Device Malfunction | Nationwide |
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| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |