SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
FDA Recall Z-0081-2010 · Posted 2009-10-26
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Recalling FirmSynthes USA (HQ), Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2009-09-03
Date Terminated2010-03-08
Product Quantity12
Reason for Recall
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
Firm 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.
Root Cause
PMA
Distribution Pattern
Nationwide Distribution -- State of CA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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