Recall Z-0077-2010
Synthes USA (HQ), Inc. · initiated September 3, 2009
Product
SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900
Codes / lots: Lot # T937853.
Reason for recall
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
FDA-determined cause: PMA
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.
Details
- Recall number
- Z-0077-2010
- Initiated
- September 3, 2009
- Posted by FDA
- October 26, 2009
- Terminated
- March 8, 2010
- Product code
- HTD – Forceps
- Quantity
- 2
- Distribution
- Nationwide Distribution -- State of CA.
- Recalling firm
- Synthes USA (HQ), Inc., West Chester, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0075-2010 | SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0076-2010 | SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967.…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0078-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog # SD448.003.…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0079-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004.…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0080-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005.…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0081-2010 | SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006.…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |
| Z-0082-2010 | SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium Matrix…The recalling firm has determined that the customized plates instruments do not have a cleared premarket… | 09/03/2009Terminated |