—#85273

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.

FDA product code: HTD — Forceps
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot # 6021104.

Why it was recalled

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

Root cause (FDA determination)

PMA

Action the firm took

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.

Recalling firm

Firm: Synthes USA (HQ), Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution -- State of CA.

Timeline

Recall initiated: 2009-09-03
Posted by FDA: 2009-10-26
Terminated: 2010-03-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85273. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.