Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.
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 potential failure of a sterile implant used in a major surgical procedure. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells, which are used in total hip arthroplasty. The recall covers product packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile.
The recall was initiated because of insufficient sealer calibration data for the affected product. The source text does not specify the exact nature of the potential harm or report any specific illnesses or injuries associated with the use of these devices.
The affected products were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 2,063
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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