The Recall Desk
HighFDA (Devices)·Z-1951-2016·Announced 2016-06-22

Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch barrier system.

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. The source text does not report any illnesses or injuries, and the hazard is related to potential loss of sterile integrity, which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

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

The recall is being conducted because the foil pouches, which are part of a dual barrier system designed to provide sterile integrity, may be compromised. The source text does not specify the exact nature of the defect or report any illnesses or injuries associated with the use of these implants.

Healthcare providers and patients who have received these specific implants should contact their healthcare provider for guidance. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM -
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 (9)

  • 00588604310 TM CR TIB SZ 3 C-H
  • 14MM 61740710 61785350 61797194 61808984 00588604317 TM CR TIB SZ 3 C-H
  • 17MM 61746678 61759782 61785351 00588604410 TM CR TIB SZ 4 C-H
  • 17MM 61746709 61770825 61785365 00588604612 TM CR TIB SZ 6 C-H
  • 17MM 61759776 61785378 61809046 00588604710 TM CR TIB SZ 7 C-H
  • 14MM 61785384 61792676 61809056 00588604717 TM CR TIB SZ 7 C-H
  • 17MM 61776822 61785385 61809057 00588604810 TM CR TIB SZ 8 C-H
  • 12MM 61769567 61776827 61792689 00588604814 TM CR TIB SZ 8 C-H
  • 14MM 61733392

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 · sterility compromise

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