Device product
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore 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.
Z-1223-2019
Product summary
- Event
- Event 82487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46
- Official record key
device-enforcement:Z-1223-2019
Official wording
Reason: Product mislabeling.
Code information: OP9519 / Lot # 00855421005864 021050617
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey.
Derived failure modes
-
Labeling or packaging
mislabeling