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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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Similar recalls
- SevereZimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
FDA (Devices) · 2013-09-04
- HighZimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
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- ModerateZimmer Biomet Recalls Reverse Shoulder Baseplates Due to Missing Adapter
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