The Recall Desk
HighFDA (Devices)·Z-1079-2014·Announced 2014-03-05

Zimmer Recalls Trabecular Metal Reverse Shoulder System Due to Disassociation

Zimmer, Inc. is recalling 73,002 units of the Trabecular Metal Reverse Shoulder System because the Glenosphere can disassociate from the Baseplate.

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, and the hazard involves a structural failure (disassociation) of a medical implant. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Zimmer, Inc. is recalling 73,002 units of the Trabecular Metal Reverse Shoulder System. The recall is being conducted because of complaints regarding the disassociation of the TM Reverse Glenosphere from the Baseplate.

The affected products were distributed worldwide, including in the United States, Germany, India, Malaysia, China, Singapore, Korea, Taiwan, and Brazil. The recall covers specific catalog numbers listed in the agency's documentation.

In response to these complaints, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.

The recalled product

Product
Trabecular Metal" Reverse Shoulder System
Manufacturer
Zimmer, Inc.
Affected units
73,002

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)

  • 61025613
  • 61009830
  • 61038635
  • 61031385
  • 61021507
  • 61021506
  • 61016907
  • 61009834
  • 61006493
  • 61006492
  • 60999239
  • 60993837
  • 60993836
  • 60987295
  • 60982839
  • 60982838
  • 60970974
  • 60970973
  • 60950253
  • 60964425

Distribution

Distributed nationwide across the United States.