Recall Z-2114-2012
Aesculap Implant Systems LLC · initiated July 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: 4 degree - SJ768T-US and 9 degree SJ780T-US
Reason for recall
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
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-2114-2012
- Initiated
- July 12, 2012
- Posted by FDA
- July 31, 2012
- Terminated
- February 22, 2013
- Product code
- HWT – Template
- Quantity
- 5
- Distribution
- US Nationwide Distribution - including the states of CO, OH, OK and TX.
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA