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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62561

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

Open FDA event record

Event summary

Timeline bucket
July 16, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Encore Medical, Lp

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

djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

Z-2146-2012
Recall number
Z-2146-2012
Initiated
July 16, 2012
Classification
Class II
Status
Terminated
Recalling firm
Encore Medical, Lp
Quantity
18 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeling

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

One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm.

Code information

Lot 007A1037, Ref 010-55-25.

Distribution pattern

Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.