CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report
The Persona Tibial Articular Surface Inserter recalled by Zimmer
Zimmer is recalling The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for, distributed nationwide in the US. The recall was initiated on 7 Oct 2014 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-0123-2015
- FDA event ID
- 69354
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2014
- FDA classified
- 23 Oct 2014
- Reported
- 29 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 7 Oct 2014 | Recall initiated by company | |
| 23 Oct 2014 | Classified by FDA | +16 days |
| 29 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Product as listed by the FDA
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial baseplate.
Where it was distributed
Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKansasMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNew JerseyNew YorkOhioOklahomaOregon
Questions about this recall
Why was it recalled?
Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
Which lots are affected?
Part Number 42-5299-001-00 Lots: 56572679; 56573170; 56572918; 56573378; 56572975; 56573379; 56572978; 56574223; 56572981; 56574291; 56572982; 56574292; 56573071; 56574316; 56573115; 56574317; 56573116; 56574318; 56573154.
Where was it sold?
Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea, Singapore, Canada and Japan
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.
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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 |