Recall Z-2114-2012— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2012-07-12, terminated 2013-02-22. FDA's recall record names no specific 510(k) clearance for this event. 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. 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.
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-12
- Terminated
- 2013-02-22
- Firm location
- Center Valley, PA, United States
Product description
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.