—#115645

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part number 03.809.690, Lot Number 6723847

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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

Timeline

Recall initiated: 2013-01-11
Posted by FDA: 2013-09-26
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115645. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.