The Recall Desk
HighFDA (Devices)·Z-1952-2016·Announced 2016-06-22

Zimmer Trabecular Metal Implants Recalled for Sterile Integrity 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 sterile 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 involves a potential loss of sterile integrity for medical implants, which is a high-risk hazard. No illnesses or injuries are reported in the source text, placing this in the 'High' category per the rubric for risk-of-harm products 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. The affected products were manufactured between April 2011 and October 2012. The recall involves 19,884 total units distributed nationwide and foreign.

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. This could potentially affect the sterility of the implants.

Healthcare providers and facilities that have received these specific lots should stop using the affected products and contact Zimmer Biomet for instructions on how to return or dispose of them. Patients who have already received these implants should consult their healthcare provider for guidance.

The recalled product

Product
TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D, 1
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)

  • 00588605310 TM LPS TIB SZ 3 C/D
  • 14MM 61759785 61770812 61797197 00588605317 TM LPS TIB SZ 3 C/D
  • 17MM 61746694 61759789 61785353 00588605410 TM LPS TIB SZ 4 C/D
  • 12MM 61733410 61844343 00588605414 TM LPS TIB SZ 4 C/D
  • 14MM 61759795 61803956 00588605510 TM LPS TIB SZ 5 E/F
  • 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F
  • 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F
  • 17MM 61733395 00588605710 TM LPS TIB SZ 7 G/H
  • 12MM 61770842 61776824 61797215 61792686 00588605714 TM LPS TIB SZ 7 G/H
  • 14MM 61739886 61770843 61797216 61792687 00588605810 TM LPS TIB SZ 8 G/H
  • 10MM 61733386 61776828 00588605812 TM LPS TIB SZ 8 G/H
  • 12MM 61733388 00588605814 TM LPS TIB SZ 8 G/H
  • 14MM 61769564 61776829 00588605814 TM LPS TIB SZ 8 G/H
  • 14MM 61803938 61809059 00588605817 TM LPS TIB SZ 8 G/H
  • 17MM 61769565 61792690 00588606310 TM LPS TIB SZ 3 E/F
  • 12MM 61746692 61770811 61785356 61792634 00588606314 TM LPS TIB SZ 3 E/F
  • 14MM 61740717 61797199 00588606317 TM LPS TIB SZ 3 E/F
  • 17MM 61785357 00588606410 TM LPS TIB SZ 4 E/F
  • 14MM 61746717 61770829 61785372 61792662 00588605517 TM LPS TIB SZ 5 E/F
  • 17MM 61746718 61770828 61809007 00588605610 TM LPS TIB SZ 6 E/F

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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