CLASS II Device recall · Reported 10 Apr 2019 · FDA Enforcement Report
Biomet Small Diameter Cement Plug Inserter-Sterile recalled
Zimmer Biomet is recalling Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation, distributed nationwide in the US. The recall was initiated on 28 Feb 2019 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-1081-2019
- FDA event ID
- 82324
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2019
- FDA classified
- 1 Apr 2019
- Reported
- 10 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 28 Feb 2019 | Recall initiated by company | |
| 1 Apr 2019 | Classified by FDA | +32 days |
| 10 Apr 2019 | 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
Lack of an adequate sterilization validation
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
Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Is Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation recalled?
Yes. Zimmer Biomet recalled Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation on 28 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1081-2019.
Why was it recalled?
Lack of an adequate sterilization validation
Which lots are affected?
All lots
Where was it sold?
Nationwide
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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