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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R)

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  Class 2 Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R) see related information
Date Initiated by Firm March 07, 2012
Date Posted July 03, 2012
Recall Status1 Terminated 3 on August 08, 2012
Recall Number Z-1934-2012
Recall Event ID 62240
Product Classification Countersink - Product Code HWW
Product S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Code Information All distributed lot numbers 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. 5000
Manufacturer Reason
for Recall		 Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision Instrument that is part of the S4C Occipital Instrument Set. The instruments may not thread into the screw properly during a revision surgery due to tolerance issues between the two instruments.
FDA Determined
Cause 2		 Component design/selection
Action The firm initiated their recall of this product by issuing an "Important Product Removal Notification" letter to all consignees dated March 7, 2012. The letter described the problem, advised them not to use the product, and instructed consignees to return the instruments to the recalling firm with the attached Distribution Inventory Sheet. Customer Service may be contacted if questions at 1-866-229-3002.
Quantity in Commerce 15
Distribution Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, 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.
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