Reported Mar 8, 2017 · Terminated

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Matrix Surgical Holdings, LLC

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: Matrix Surgical Holdings, LLC · 4025 Welcome All Rd Sw Ste 120 · Atlanta, GA · 30349-1876

Is this the product you have?

  • OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Lot codes and dates
  • OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
Amount recalled
28

Why it was recalled

Mislabeling. The packaging labeled as left mandible contained a right mandible.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Matrix Surgical Holdings, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 24, 2017 · Data as of Sep 19, 5:22 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.