Zimmer Recalls Trilogy Acet Shell and Bone Screw Medical Devices
Zimmer is recalling Trilogy Acet Shell and Bone Screw devices due to unvalidated packaging operations at its Puerto Rico facility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text indicates that seal integrity testing met acceptance criteria and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall or low-risk contamination issue.
Plain-English summary
Zimmer, Inc. is recalling specific lots of Trilogy Acet Shell and Bone Screw medical devices. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed the packaging met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility area.
Healthcare providers and patients should check their inventory or medical records for these specific device lots. If you have these devices, contact Zimmer or your healthcare provider for instructions on how to proceed.
The recalled product
- Product
- TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY ACET SHELL 46MM O TRILOGY ACET SHELL 48MM O TRILOGY ACET SHELL 50MM O TRILOGY ACET SHELL 52MM O TRILOGY ACET SHELL 54MM O TRILOGY AC
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, 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.
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