FDA Devices recall · Reported December 24, 2014
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. 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 noninfla
Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of…
Zimmer Manufacturing B.v. recalled Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, … - a moderate-severity action.
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, … was recalled by Zimmer Manufacturing B.v. in December 24, 2014. Reason: Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified…. Check the official notice for the remedy. Verify recall #Z-0824-2015 with the FDA Devices before acting.
The recall
Zimmer Manufacturing B.v. issued this moderate-severity FDA Devices recall-Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- December 24, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0824-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. 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 degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Reason for recall
Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0824-2015 |
| Date reported | December 24, 2014 |
| Date initiated | November 21, 2014 |
| Recalling firm | Zimmer Manufacturing B.v. |
| Firm location | N/A |
| Affected scope | 6,377 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Islands Czech Republic Denmark Egypt Finland … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0824-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026