Zimmer Recalls Trilogy Fiber Metal Acetabular Shell Due to Thread Defect
Zimmer Manufacturing B.V. is recalling 68 units of Trilogy Fiber Metal Acetabular Shells because the polar-hole threads were found to be undersized, preventing proper attachment to surgical instruments.
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 text describes a manufacturing defect (undersized threads) that prevented instrument attachment but does not report any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 68 units of the Trilogy Fiber Metal Acetabular Shell, Size 54 mm OD (Item No. 00-6200-054-20, Lot 62714305). The product is indicated for cemented or uncemented use in primary or revision hip surgery for skeletally mature individuals.
The recall was initiated after Zimmer received a single complaint stating that a Trilogy Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. An investigation determined that the polar-hole threads were present but non-conforming to specifications, specifically that the minor diameter was undersized. The issue is isolated to Lot 62714305.
The affected units were distributed worldwide, including the United States (nationwide), France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and the United Kingdom. Healthcare providers and patients should check their inventory or surgical records for this specific lot number and contact Zimmer or their local FDA office for further instructions.
The recalled product
- Product
- Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD 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 result of noninflammatory degenerat
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 68
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)
- Item No. 00-6200-054-20
- Lot 62714305
Distribution
Distributed nationwide across the United States.
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