Recall Z-0973-2015 ยท GAD Retractor
Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
| Date | Jan 14, 2015 (initiated Dec 15, 2014) |
| Status | Terminated |
| Reason | Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material. Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection. |
| Root cause | Component design/selection |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated December 15, 2014, to its end users and sales consultants. The letter identified the product, problem, and actions to be taken. The End users/sales staff were instructed to immediately remove affected stock from inventory; call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number; complete and return the attached Verification Section to DePuy Synthes via fax: 866-827-3421 or Scan/email: Synthes8645@stericycly.com, even if you do not have any of the affected product, and return any affe |
| Quantity | 1762 |
| Distribution | Worldwide Distribution: US (nationwide) and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.