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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93623

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 05, 2023
Product types
Device
Classifications
Class II
Statuses
Completed
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

2 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 2

Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

Z-0625-2024
Recall number
Z-0625-2024
Initiated
October 05, 2023
Classification
Class II
Status
Completed
Recalling firm
Encore Medical, LP
Quantity
17 units

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 process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeling

Code information

UDI: (01)00888912144612/Lot Number(s): 381P1167

Distribution pattern

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

device · product 2 of 2

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Z-0626-2024
Recall number
Z-0626-2024
Initiated
October 05, 2023
Classification
Class II
Status
Completed
Recalling firm
Encore Medical, LP
Quantity
2 units

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 process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeling

Code information

UDI: (01)00888912108560/Lot Number(s): 157N1556

Distribution pattern

US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.