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Z-1223-2019 Class II Terminated

Recalled by Matrix Surgical Holdings, LLC — Atlanta, GA

FDA device recall Z-1223-2019 was initiated by Matrix Surgical Holdings, LLC on January 30, 2019 and is designated Class II. Reason for recall: Product mislabeling. The recall status is terminated (terminated June 23, 2020). Affected quantity: 46.

Recall Details

Product Type: Devices
Report Date: May 8, 2019
Initiation Date: January 30, 2019
Termination Date: June 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46

Product Description

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.

Reason for Recall

Product mislabeling.

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.

Code Information

OP9519 / Lot # 00855421005864 021050617