Zimmer Manufacturing Recalls Trilogy Acet Shell Hip Implant Components
Zimmer Manufacturing B.V. is recalling 400 units of Trilogy Acet Shell hip implant components due to insufficient sealer calibration data.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to calibration data rather than a confirmed high-risk pathogen or structural failure.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 400 units of the Trilogy Acet Shell 36MM OD MULTI, a component used in total hip arthroplasty. The affected products are sterile and were packaged in the firm's Building II between August 2010 and April 2013.
The recall was initiated because of insufficient sealer calibration data for the product. The specific lot number for the recalled items is 62313588. The products were distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected products and contact Zimmer Manufacturing B.V. for further instructions on how to return or dispose of the items.
The recalled product
- Product
- Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Hazard
- Affected units
- 400
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 (1)
- lot no.: 62313588
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. 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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