CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
Femoral Nail, A/R T2 Femur mm T2 Femoral Nailing System recalled
Stryker Howmedica Osteonics is recalling Femoral Nail, A/R T2 Femur mm T2 Femoral Nailing System is one of the first femoral, distributed in California. The recall was initiated on 30 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2792-2016
- FDA event ID
- 74727
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2016
- FDA classified
- 13 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 30 Jun 2016 | Recall initiated by company | |
| 13 Sep 2016 | Classified by FDA | +75 days |
| 21 Sep 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Product as listed by the FDA
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
Where it was distributed
US distribution to state of: CA.
Questions about this recall
Why was it recalled?
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Which lots are affected?
Catalog number 18251032S and Lot Code K288335
Where was it sold?
US distribution to state of: CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 74727This product is part of a recall event; the main page for the event is Supracondylar Nail T2 SCN mm T2 Supracondylar Nail System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Supracondylar Nail T2 SCN mm T2 Supracondylar Nail System recalled | Stryker Howmedica Osteonics | Labeling Errors | CA |
More recalls from Stryker Howmedica Osteonics
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) recalled | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Reunion TSA Peg Alignment Sound recalled by Stryker Howmedica Osteonics | Stryker Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
| Device | CLASS II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled | Stryker Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled | Stryker Howmedica Osteonics | Other | NJ |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |