CLASS II Device recall · Reported 18 Nov 2015 · FDA Enforcement Report
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads recalled
Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads, distributed nationwide in the US. The recall was initiated on 8 Sep 2015 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-0261-2016
- FDA event ID
- 72297
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 8 Sep 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +63 days |
| 18 Nov 2015 | 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
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Product as listed by the FDA
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads on 8 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0261-2016.
Why was it recalled?
Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
Which lots are affected?
Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332 exp- dates july 2019 to august 2019
Where was it sold?
Nationwide Distribution
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 | Sterility | Nationwide |
| Device | CLASS II | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |