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.
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