CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
Comprehensive VRS Inserter, shoulder prosthesis recalled by Biomet
Biomet is recalling Comprehensive VRS Inserter, shoulder prosthesis, distributed nationwide in the US. The recall was initiated on 11 May 2020 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-2300-2020
- FDA event ID
- 85658
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 May 2020
- FDA classified
- 8 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 11 May 2020 | Recall initiated by company | |
| 8 Jun 2020 | Classified by FDA | +28 days |
| 17 Jun 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Where it was distributed
US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
Nationwide CaliforniaFloridaIndianaKansasKentuckyMichiganOhioTexas
Questions about this recall
Is Comprehensive VRS Inserter, shoulder prosthesis recalled?
Yes. Biomet recalled Comprehensive VRS Inserter, shoulder prosthesis on 11 May 2020. The recall is Class II and its status is Terminated. Recall number Z-2300-2020.
Why was it recalled?
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
Which lots are affected?
Lots 814100, 570640, 728890, 977300
Where was it sold?
US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
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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