FDA Devices recall · Reported August 29, 2012
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with
In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etc…
DePuy Orthopaedics, Inc. recalled Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the… - a moderate-severity action.
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the… was recalled by DePuy Orthopaedics, Inc. in August 29, 2012. Reason: In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136…. Check the official notice for the remedy. Verify recall #Z-2220-2012 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136….
- Moderate
- severity level
- Class II
- classification
- August 29, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2220-2012 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
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Reason for recall
In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2220-2012 |
| Date reported | August 29, 2012 |
| Date initiated | July 24, 2012 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 20 liners |
| Distribution | Worldwide Distribution - USA including PA and the country of Canada |
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-2220-2012) 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