FDA Medical Device Recalls (openFDA)
Synthes USA HQ, Inc.: 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.
- Recall number
- Z-2282-2013
- Recalling firm
- Synthes USA HQ, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-01-11
- Posted
- 2013-09-26
- Terminated
- 2015-08-31
- 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.
- Root cause
- 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
- 27
- Distribution
- Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
- Lot, serial or model codes
- Part number 03.809.690, Lot Number 6723847
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005180112
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28