Recall Z-0075-2010 ยท HTD Forceps
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.
| Date | Oct 26, 2009 (initiated Sep 3, 2009) |
| Status | Terminated |
| Reason | The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification. |
| 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 | 1 |
| Distribution | Nationwide Distribution -- State of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.