Z-2333-2012Class II

Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4...

Name: Z-2333-2012 Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4...
Creator: Aesculap Implant Systems LLC
Published: 2012-07-25
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-07-25 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral... on 2012-07-25. FDA classified it as Class II and gives the reason as "There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert...". 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-2333-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Posted: 2012-09-07
Terminated: 2014-03-18
Recalling firm: Aesculap Inc
Product: Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: There is a possibility that the screw channel that holds the rod in place may be out of tolerance. When the depth of the channel is not deep enough, the rod may not be able to provide ample compression on the insert preventing the screw head from locking down to the bone screw.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Aesculap sent an "IMPORTANT PRODUCT REMOVAL NOTIFICATION" letter dated July 25, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Distribution Inventory Sheet was attached for customers to complete and return with the affected product. Contact the firm at (610) 984-9275 for questions regarding this recall.
Quantity in commerce: 5
Distribution: Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.
Product codes and lots: All distributed lots and serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2333-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2333-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code NKB

K100623Class IIAesculap Implant Systems S4 Spinal SystemAesculap Implant Systems / cleared 2010-06-09

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)