Z-2114-2012Class II

Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US)

Name: Z-2114-2012 Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US)
Creator: Aesculap Implant Systems LLC
Published: 2012-07-12
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-07-12 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2012-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2114-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-12
Posted: 2012-07-31
Terminated: 2013-02-22
Recalling firm: Aesculap Inc
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
Product code: HWT Template
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
Root cause tag: manufacturing process
FDA 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 in commerce: 5
Distribution: US Nationwide Distribution - including the states of CO, OH, OK and TX.
Product codes and lots: 4 degree - SJ768T-US and 9 degree SJ780T-US

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2114-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2114-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-07-31

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)