Aesculap Implant Systems LLC: Medical Device Recall in 2012 - (Recall #: Z-2333-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 25, 2012

Date Posted: September 19, 2012

Recall Number: Z-2333-2012

Event ID: 62842

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.

Status: Terminated

Product Quantity: 5

Code Information:

All distributed lots and serial numbers

Distribution Pattern:

Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated