Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.
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 source text does not report any illnesses or injuries. 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 275,952 units of Trilogy Acetabular Shells with holes. The recall includes lots of Uni-Hole Trilogy Acetabular System shells, which were added to the action on October 31, 2012. These devices are indicated for cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
The recall is due to a manufacturing defect where some units produced since March 2009 may have porosity levels below the lower range of the specification. Specifically, some units may have porosity as low as 28%, whereas the specification requires 30%. This deviation from the pore size specification may impact the performance of the implant.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, India, Japan, and various European countries. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 275,952
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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