FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0075-2010
- Recalling firm
- Synthes USA (HQ), Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-09-03
- Posted
- 2009-10-26
- Terminated
- 2010-03-08
- 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.
- Lot, serial or model codes
- Lot # 6021104.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTD
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28