Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0824-2015) was formally reported on December 24, 2014, with the manufacturer initiating the action on November 21, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Manufacturing B.v. is listed as the recalling firm, operating out of N/A. Federal records list the affected scope as 6,377.
The documented reason for this recall is: 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. . Distribution data in the federal record shows the product reached: 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 De…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
6,377
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Manufacturing B.v.. Units affected: 6,377.
Why was this product recalled? ▼
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. .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0824-2015.
Where was the recalled product distributed? ▼
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 France Germany Greece Hungary Ireland Italy Netherlands Norway Poland Portugal Russia Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0824-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 24, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.