Recall Z-2333-2012— Aesculap Implant Systems LLC

Name: FDA recall Z-2333-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-25

Class II · Terminated

Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2012-07-25, terminated 2014-03-18. It names one FDA 510(k) clearance: K100623. 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.. Reason: 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..

Recalling firm: Aesculap Implant Systems LLC
Classification: Class II
Status: Terminated
Initiated: 2012-07-25
Terminated: 2014-03-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K100623 — AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMAesculap Implant Systems·cleared 2010-06-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.