CLASS II Device recall · Reported 22 Aug 2018 · FDA Enforcement Report
Arcos Modular Revision Hip System recalled by Zimmer Biomet
Zimmer Biomet is recalling Arcos Modular Revision Hip System, distributed in California, Georgia, Illinois, Missouri, New York, Virginia. The recall was initiated on 8 Jun 2018 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-2820-2018
- FDA event ID
- 80534
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2018
- FDA classified
- 14 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 8 Jun 2018 | Recall initiated by company | |
| 14 Aug 2018 | Classified by FDA | +67 days |
| 22 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Product as listed by the FDA
ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
Where it was distributed
US distribution to CA, GA, IL, MO, NY, and VA.
Questions about this recall
Is Arcos Modular Revision Hip System recalled?
Yes. Zimmer Biomet recalled Arcos Modular Revision Hip System on 8 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2820-2018.
Why was it recalled?
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
Which lots are affected?
lot 621550 UDI (01)00880304474154(17)280206(10)621550
Where was it sold?
US distribution to CA, GA, IL, MO, NY, and VA.
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
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 | Nitrosamine Impurity | 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) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |