Exact FDA event identifier

Event 87975

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

Open FDA event record

Event summary

Timeline bucket: May 07, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: DePuy Orthopaedics, 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

DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

Z-1845-2021

Recall number: Z-1845-2021
Initiated: May 07, 2021
Classification: Class II
Status: Terminated
Recalling firm: DePuy Orthopaedics, Inc.
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

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

Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

Code information

Lot: D20111130 GTIN: 10603295033172

Distribution pattern

Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda