Z-0075-2010

SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal...

Name: Z-0075-2010 SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal...
Creator: Synthes USA (HQ), Inc.
Published: 2009-09-03
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-09-03 / Terminated

FDA source

Synthes USA (HQ), Inc. began a recall of SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in... on 2009-09-03. The reason FDA records is "The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0075-2010
Status: Terminated
Initiated: 2009-09-03
Posted: 2009-10-26
Terminated: 2010-03-08
Recalling firm: Synthes GmbH
Product: SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
Product code: HTD Forceps
Reason for recall: The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
FDA root cause: PMA
Action: The customer account was notified by an Urgent: Medical Device Removal letter via USPS certified mail on 9/4/2009. The letter stated that the products did not have clearance for the hospital's intended use and that if the customer has any of the identified devices, they should call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Also, the customer should complete the Verification Section, and return the letter along with any remaining product. For questions the hospital could call 610-719-5865.
Quantity in commerce: 1
Distribution: Nationwide Distribution -- State of CA.
Product codes and lots: Lot # 6021104.

Product code HTD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)