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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66990

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2013
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

Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer 0.5 g Gentamicin, Distributed by Zimmer Dover, OH 44522 The cement is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

Z-0730-2014
Recall number
Z-0730-2014
Initiated
November 04, 2013
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
1,534 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.

Code information

Cat No. 00-1113-140-01; lot 75974340

Distribution pattern

Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI, WV & WY.