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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86450

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

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Event summary

Timeline bucket
September 09, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

Z-0135-2021
Recall number
Z-0135-2021
Initiated
September 09, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Encore Medical, LP
Quantity
12 cups

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

Code information

Model Number: 940-02-54G Lot Number: 801Z1036

Distribution pattern

U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.