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Z-1382-2017 Class II Terminated

Recalled by Matrix Surgical Holdings, LLC — Atlanta, GA

FDA device recall Z-1382-2017 was initiated by Matrix Surgical Holdings, LLC on January 25, 2017 and is designated Class II. Reason for recall: Mislabeling. The packaging labeled as left mandible contained a right mandible. The recall status is terminated (terminated May 24, 2017). Affected quantity: 28.

Recall Details

Product Type: Devices
Report Date: March 8, 2017
Initiation Date: January 25, 2017
Termination Date: May 24, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

Code Information

OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)