FDA Devices recall · Reported January 16, 2013
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Stryker Howmedica Osteonics Corp. recalled Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 de… - a moderate-severity action.
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 de… was recalled by Stryker Howmedica Osteonics Corp. in January 16, 2013. Reason: Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible…. Check the official notice for the remedy. Verify recall #Z-0656-2013 with the FDA Devices before acting.
The recall
Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible….
- Moderate
- severity level
- Class II
- classification
- January 16, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0656-2013 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
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
Reason for recall
Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0656-2013 |
| Date reported | January 16, 2013 |
| Date initiated | October 23, 2012 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 6021-2530- four units; 6021-3535- |
| Distribution | Nationwide distribution, including the states of NY, NJ, CA and FL. |
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-0656-2013) 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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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
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Methodology · Corrections · Archive as of August 2026