Exact FDA event identifier

Event 68006

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

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Event summary

Timeline bucket: April 08, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Synthes, 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 XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).

Z-1681-2014

Recall number: Z-1681-2014
Initiated: April 08, 2014
Classification: Class II
Status: Terminated
Recalling firm: Synthes, Inc.
Quantity: 3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Code information

Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

Distribution pattern

US Distribution including the states of FL, NJ and MN.