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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71560

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

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Event summary

Timeline bucket
June 15, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pega Medical 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

Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.

Z-1848-2015
Recall number
Z-1848-2015
Initiated
June 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
Pega Medical Inc.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.

Code information

Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.

Distribution pattern

US Distribution to the states of : FL and TN.