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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690

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 Class 2 Recall
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690
see related information
Date Posted September 26, 2013
Recall Status1 Open
Recall Number Z-2282-2013
Recall Event ID 64236
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
Code Information Part number 03.809.690, Lot Number 6723847
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer Reason
for Recall
This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
FDA Determined
Cause 2
DESIGN: Device Design
Action SYNTHES sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees examine their inventory, remove the recalled product from use and return them to Synthes. Customers were also instructed to completed the attached Verification Section at the end of the letter indicating whether or not they had any of the affected product and the number of devices found. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 27
Distribution Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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