The Recall Desk
HighFDA (Devices)·Z-1955-2016·Announced 2016-06-22

Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants. The affected products were manufactured between April 2011 and October 2012. The recall involves 19,884 total units distributed nationwide and to foreign locations.

The recall is being conducted because the foil pouches are part of a dual barrier system designed to provide sterile integrity. The source text indicates that the recall is initiated to address this aspect of the packaging system.

Healthcare providers and facilities that have received these specific lots of Trabecular Metal implants should contact Zimmer Biomet for further instructions on how to handle the recalled products.

The recalled product

Product
00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACET
Manufacturer
Zimmer Trabecular Metal Technology, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
19,884

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 00720504022 ACETAB.CUPW/SH
  • 0DEG
  • 22MMX40MM 61868161 00720504222 ACETAB.CUPW/SH
  • 22MMX42MM 62075682 00720504622 ACETAB.CUPW/SH
  • 22MMX46MM 61868174 00720504828 ACETAB.CUPW/SH
  • 28MMX48MM 62099999 00720505228 ACETAB.CUPW/SH
  • 28MMX52MM 61985379 00720505628 ACETAB.CUPW/SH
  • 28MMX56MM 61739647 00720505828 ACETAB.CUPW/SH
  • 28MMX58MM 61859335 00720506028 ACETAB.CUPW/SH
  • 28MMX60MM 61868180 00720506228 ACETAB.CUPW/SH
  • 28MMX62MM 61885454 61912432 00720506428 ACETAB.CUPW/SH
  • 28MMX64MM 61763307 00721004222 ACETAB.CUPW/SH
  • 10DEG
  • 22MMX42MM 62075683 00721004422 ACETAB.CUPW/SH
  • 22MMX44MM 61792574 00721005028 ACETAB.CUPW/SH
  • 28MMX50MM 61747148 61770547 61859658 00721005228 ACETAB.CUPW/SH
  • 28MMX52MM 61747106 61812211 61830726 00721005628 ACETAB.CUPW/SH
  • 28MMX56MM 62020209 00721006428 ACETAB.CUPW/SH
  • 28MMX64MM 61836505 61855146 61954911 00721006628 ACETAB.CUPW/SH
  • 28MMX66MM 61830949 00721006828 ACETAB.CUPW/SH

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Zimmer Trabecular Metal Technology, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Zimmer Trabecular Metal Technology, Inc.

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Same hazard · sterile integrity

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