Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap S4 Element 4.5mm Polyaxial Screws

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Aesculap S4 Element 4.5mm Polyaxial Screws see related information
Date Initiated by Firm July 25, 2012
Date Posted September 07, 2012
Recall Status1 Terminated 3 on March 18, 2014
Recall Number Z-2333-2012
Recall Event ID 62842
510(K)Number K100623  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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.
Code Information All distributed lots and serial numbers
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact
800-258-1946 Ext. 5067
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = AESCULAP IMPLANT SYSTEMS
-
-