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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90557

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

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Event summary

Timeline bucket
June 29, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
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 Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

Z-1419-2022
Recall number
Z-1419-2022
Initiated
June 29, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
872 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

Code information

GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

Distribution pattern

Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

Field note

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