Matrix Surgical Holdings, LLC: Medical Device Recall in 2017 - (Recall #: Z-1382-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 25, 2017

Date Posted: March 8, 2017

Recall Number: Z-1382-2017

Event ID: 76356

Reason for Recall:

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

Status: Terminated

Product Quantity: 28

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated