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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68801

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

Open FDA event record

Event summary

Timeline bucket
July 30, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer, 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

Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.

Z-2543-2014
Recall number
Z-2543-2014
Initiated
July 30, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
2,248 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.

Code information

Item Number 42509900400, Lot Number: 62313324, 62415340, 62561031, 62668655, 62313326, 62430425, 62580270, 62695918, 62341561, 62442314, 62590506, 62702686, 62358628, 62473246, 62594059, 62715932, 62368700, 62507846, 62611157, 62728374, 62376588, 62522771, 62624943, 62742362, 62396348, 62530133, 62637095, 62749057, 62401156, 62534170, 62641120, 62757397, 62407514, 62538842, 62662172, 62766074, 62410673, 62542958, & 62668654.

Distribution pattern

Worldwide Distribution -- United States, including Puerto Rico; and, to the countries of Australia, Austria, Japan, Belgium, Italy, Switzerland, India, Germany, Spain, France, Israel, Netherlands, Saudi Arabia, South Africa & Canada.