Recall Z-2114-2012 ยท HWT Template
Aesculap Implant Systems LLC
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
| Date | Jul 31, 2012 (initiated Jul 12, 2012) |
| Status | Terminated |
| Reason | The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree tria |
| Root cause | Employee error |
| Action | Aesculap sent an Important Product Removal Notification letter dated July 11, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to return the affected product by contacting their local sales representative or the customer service department at 1-866-229-3002 for a Returned Goods Request )RGR) number. Customers were asked to complete and return the Distribution Inventory Sheet. For questions call 610-984-9260 or 610-984-9274. |
| Quantity | 5 |
| Distribution | US Nationwide Distribution - including the states of CO, OH, OK and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.