Reported Dec 30, 2020 · Terminated

Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not…

Biocomposites, Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocomposites, Ltd. · Keele Science Park · Keele Staffordshire, N/A · N/A

Is this the product you have?

  • Stimulan Kit 10cc
  • Model 600-010 - Product Usageintended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure
Lot codes and dates
    • Lot SK190610
    • Expiry June 2022
Amount recalled
54 boxes

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The product is mislabeled.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 27, 2021 · Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.