Exact FDA event identifier

Event 72529

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

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Event summary

Timeline bucket: October 20, 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

SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.

Z-0324-2016

Recall number: Z-0324-2016
Initiated: October 20, 2015
Classification: Class II
Status: Terminated
Recalling firm: Pega Medical Inc.
Quantity: 4 units distributed in the US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.

Code information

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

Distribution pattern

Distributed in the states of FL and TN.