Z-1382-2017Class II

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

Name: Z-1382-2017 OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Creator: Matrix Surgical Holdings, LLC
Published: 2017-01-25
License: https://open.fda.gov/license/

MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA / initiated 2017-01-25 / Terminated / root cause: labeling and UDI

FDA source

Matrix Surgical Holdings, LLC began a recall of OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right on 2017-01-25. FDA classified it as Class II and gives the reason as "Mislabeling. The packaging labeled as left mandible contained a right mandible". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1382-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Posted: 2017-02-28
Terminated: 2017-05-24
Recalling firm: MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA
Product: OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
Product code: KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Reason for recall: Mislabeling. The packaging labeled as left mandible contained a right mandible.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794.
Quantity in commerce: 28
Distribution: Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
Product codes and lots: OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1382-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-02-28

Product code KKY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)