CLASS II Device recall · Reported 8 Apr 2015 · FDA Enforcement Report
Persona¿ Anterior Referencing Sizer recalled by Zimmer
Zimmer is recalling Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing, distributed nationwide in the US. The recall was initiated on 10 Mar 2015 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-1360-2015
- FDA event ID
- 70676
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Mar 2015
- FDA classified
- 1 Apr 2015
- Reported
- 8 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 10 Mar 2015 | Recall initiated by company | |
| 1 Apr 2015 | Classified by FDA | +22 days |
| 8 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
Where it was distributed
Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIllinoisIndianaKansasMassachusettsMaineMichiganMinnesotaMississippiNorth CarolinaNew JerseyNew YorkOhioOklahoma
Questions about this recall
Is Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing recalled?
Yes. Zimmer recalled Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing on 10 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1360-2015.
Why was it recalled?
Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
Which lots are affected?
Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;
Where was it sold?
Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.
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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Other Hip & Knee Implants recalls
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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 | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |