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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79043

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 10, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes USA

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

2 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 2

Norian Drillable Inject

Z-0617-2018
Recall number
Z-0617-2018
Initiated
August 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA
Quantity
239 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

Code information

Product Number: 07.704.003S Lot Number: DSD9110

Distribution pattern

Nationwide Distribution.

device · product 2 of 2

Norian Drillable Inject

Z-0618-2018
Recall number
Z-0618-2018
Initiated
August 10, 2017
Classification
Class II
Status
Terminated
Recalling firm
Synthes USA
Quantity
5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

Code information

Product Number: 07.704.010S Lot Number: DSE0733

Distribution pattern

Nationwide Distribution.