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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64236

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 11, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes USA HQ, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2282-2013
Recall number
Z-2282-2013
Initiated
January 11, 2013
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA HQ, Inc.
Quantity
27

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

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.