Exact FDA event identifier

Event 88722

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, 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

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

Z-0074-2022

Recall number: Z-0074-2022
Initiated: September 09, 2021
Classification: Class II
Status: Terminated
Recalling firm: DePuy Orthopaedics, Inc.
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

Code information

Lot Number: J6304Z GTIN: 10603295057642

Distribution pattern

US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.