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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64993

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

Open FDA event record

Event summary

Timeline bucket
August 29, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SpineFrontier, 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

T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.

Z-1932-2013
Recall number
Z-1932-2013
Initiated
August 29, 2012
Classification
Class II
Status
Terminated
Recalling firm
SpineFrontier, Inc.
Quantity
11

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.

Code information

Lot Numbers: 1335201A, 1446101A

Distribution pattern

US Distribution including the states of MA, NV and TX.