Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2282-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: October 2, 2013

Recall Number: Z-2282-2013

Event ID: 64236

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.

Status: Terminated

Product Quantity: 27

Code Information:

Part number 03.809.690, Lot Number 6723847

Distribution Pattern:

Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated