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.
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 2/5 (Moderate).
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…
- 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.
Related recalls
Same manufacturer · Zimmer Manufacturing B.V.
See all →- HighZimmer 3.5 mm Cortical Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-05-25
- HighZimmer Manufacturing Recalls Sterile Hip and Trauma Implant Screws
FDA (Devices) · 2016-05-25
- HighZimmer VersaFx Femoral Fixation System Screws Recalled for Sterility Concerns
FDA (Devices) · 2016-05-25
- HighZimmer Herbert Cannulated Bone Screw Recall for Sterility Concerns
FDA (Devices) · 2016-05-25
- ModerateZimmer Recalls Sterile Hip and Trauma Implant Screws Due to Tray Defect
FDA (Devices) · 2016-05-25
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateZimmer Recalls Trilogy Acetabular System Shells Due to Missing Threads
FDA (Devices) · 2012-11-28
- HighZimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells with Porosity Defects
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects
FDA (Devices) · 2013-02-13
- HighZimmer Recalls Trilogy Acetabular Shells for Porosity Defects
FDA (Devices) · 2013-02-13