Synthes USA (HQ), Inc. 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Synthes USA (HQ), Inc.
Lot Codes / Batch Numbers
Lot # 6021104.
Products Sold
Lot # 6021104.
Synthes USA (HQ), Inc. is recalling SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagi due to The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026