FDA Device recall Z-2114-2012
Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant S…
- FDA Device
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant S… by Aesculap Implant Systems, citing 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 inst….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2114-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-12 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap Implant Systems |
| Distribution | US |
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
Identifiers
| code_info | 4 degree - SJ768T-US and 9 degree SJ780T-US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2114-2012%22
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