Recall Z-2282-2013— Synthes USA HQ, Inc.

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2013-01-11, terminated 2015-08-31. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Synthes USA HQ, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-01-11

Terminated

2015-08-31

Firm location

West Chester, PA, United States

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