CLASS II Device recall · Reported 22 Jun 2016 · FDA Enforcement Report
Dome Centric component (Reference 04227.005) from recalled by Zimmer
Zimmer is recalling Dome Centric component (Reference 04227.005) from the Anatomical Shoulder (AS) System 0, distributed nationwide in the US. The recall was initiated on 17 May 2016 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-2003-2016
- FDA event ID
- 74206
- Recalling firm
- Zimmer, Winterthur
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 May 2016
- FDA classified
- 16 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 May 2016 | Recall initiated by company | |
| 16 Jun 2016 | Classified by FDA | +30 days |
| 22 Jun 2016 | 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
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
Product as listed by the FDA
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Where it was distributed
Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
Nationwide ArizonaCaliforniaColoradoGeorgiaIllinoisKansasKentuckyMassachusettsMarylandMissouriOhioPennsylvaniaTennesseeTexas
Stores named: Walmart
Questions about this recall
Is Dome Centric component (Reference 04227.005) from the Anatomical Shoulder (AS) System 0 recalled?
Yes. Zimmer recalled Dome Centric component (Reference 04227.005) from the Anatomical Shoulder (AS) System 0 on 17 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2003-2016.
Why was it recalled?
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
Which lots are affected?
Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862
Where was it sold?
Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
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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