Recall Z-1382-2017— Matrix Surgical Holdings, LLC

Name: FDA recall Z-1382-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-25

Class II · Terminated

Class II FDA medical device recall by Matrix Surgical Holdings, LLC, initiated 2017-01-25, terminated 2017-05-24. It names 2 FDA 510(k) clearances: K133046, K123908. Product: OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right. Reason: Mislabeling. The packaging labeled as left mandible contained a right mandible..

Recalling firm: Matrix Surgical Holdings, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Terminated: 2017-05-24
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

2 on FDA's record

K133046 — OMNIPORE CUSTOMIZED SURGICAL IMPLANTSMatrix Surgical Holdings, LLC/Matrix Surgical USA·cleared 2014-05-14
K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA·cleared 2013-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.