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ModerateClass IITerminated

FDA Devices recall · Reported September 21, 2016

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fra

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Recall #
Z-2792-2016
Affected scope
1 unit in total
Initiated
June 30, 2016
Verify with FDA Devices →
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Stryker Howmedica Osteonics Corp. recalled Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first fe… - a moderate-severity action.

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first fe… was recalled by Stryker Howmedica Osteonics Corp. in September 21, 2016. Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.. Check the official notice for the remedy. Verify recall #Z-2792-2016 with the FDA Devices before acting.

The recall

Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field..

Moderate
severity level
1 units
affected scope
Class II
classification
September 21, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2792-2016 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

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

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

Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions

Reason for recall

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2792-2016
Date reported September 21, 2016
Date initiated June 30, 2016
Recalling firm Stryker Howmedica Osteonics Corp.
Firm location Mahwah, NJ
Affected scope 1 unit in total
Distribution US distribution to state of: CA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1 unit in total units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2792-2016) 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?
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions. Recalled by Stryker Howmedica Osteonics Corp.. Units affected: 1 unit in total.
Why was this product recalled?
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2792-2016.
Where was the recalled product distributed?
Distribution: US distribution to state of: CA..
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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported September 21, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026