Z-2282-2013Class II

Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is...

Name: Z-2282-2013 Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is...
Creator: Synthes USA HQ, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-01-11 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of 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... on 2013-01-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2282-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-09-26
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA 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 [email protected]. 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.
Product codes and lots: Part number 03.809.690, Lot Number 6723847

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2282-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2282-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-26

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)