SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006. Synthes Titanium Matrix Mandible Sag

FDA device recall Z-0081-2010 · posted 2009-10-26 · Terminated

Recall details

Recalling firm

Synthes USA (HQ), Inc.

Reason for recall

The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.

Action taken

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

Status

Terminated

Product code

JEY

Quantity affected

12

Distribution

Nationwide Distribution -- State of CA.

Date initiated

2009-09-03

Date posted

2009-10-26

Date terminated

2010-03-08

Location

West Chester, PA