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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72345

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

Open FDA event record

Event summary

Timeline bucket
October 06, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes (USA) Products LLC

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

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Z-0167-2016
Recall number
Z-0167-2016
Initiated
October 06, 2015
Classification
Class II
Status
Terminated
Quantity
98

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

Code information

Part Number 202.212 Lot Number 3420620

Distribution pattern

US Distribution to the state of : TN