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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78960

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

Open FDA event record

Event summary

Timeline bucket
July 24, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ZIMMER ORTHOPEDIC MFG LTD

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

NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.

Z-0663-2018
Recall number
Z-0663-2018
Initiated
July 24, 2017
Classification
Class II
Status
Terminated
Recalling firm
ZIMMER ORTHOPEDIC MFG LTD
Quantity
7 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

Code information

Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)

Distribution pattern

Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.