Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The

FDA device recall Z-2114-2012 · posted 2012-07-31 · Terminated

Recall details

Recalling firm

Aesculap Implant Systems LLC

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

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.

Root cause

Employee error

Status

Terminated

Product code

HWT

Quantity affected

5

Distribution

US Nationwide Distribution - including the states of CO, OH, OK and TX.

Date initiated

2012-07-12

Date posted

2012-07-31

Date terminated

2013-02-22

Location

Center Valley, PA