Reported May 8, 2019 · Terminated
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and…
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?
- OMNIPORE Surgical Implant Petite
- Paranasal - Right - Product UsageOmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton
- Lot codes and dates
- OP9520 / Lot # 00855421005871 022050617
- Amount recalled
- 42
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Product mislabeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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