Zimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads
Zimmer, Inc. is recalling 95 units of the Trilogy Acetabular System Shell with Cluster Holes because they are missing polar hole threads. No injuries were reported.
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, and the source explicitly states that no injury was reported, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling the Trilogy Acetabular System Shell with Cluster Holes, Porous, 56 mm O.D., sterile. The recall involves 24 units in the United States and 71 units worldwide. The specific product is identified by REF 6200-056-22 and lot 62010615.
The reason for the recall is that the product is missing polar hole threads. The device is indicated for use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged by noninflammatory degenerative joint disease or related conditions.
The affected units were distributed nationwide in the United States, including in Alabama, California, Connecticut, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New York, South Dakota, Texas, and Wisconsin. They were also distributed in Bulgaria, Canada, Germany, Italy, the Netherlands, the Russian Federation, Sweden, and the United Kingdom. Zimmer received one complaint regarding this issue, and no injury was reported.
The recalled product
- Product
- The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a r
- Manufacturer
- Zimmer, Inc.
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 (2)
- REF 6200-056-22
- lot 62010615
Distribution
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