CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
UOC Femoral Driver, Product number PE recalled by United Orthopedic
United Orthopedic is recalling UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical, distributed in California. The recall was initiated on 10 Feb 2017 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-1692-2017
- FDA event ID
- 76540
- Recalling firm
- United Orthopedic, Hsinchu
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2017
- FDA classified
- 29 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 10 Feb 2017 | Recall initiated by company | |
| 29 Mar 2017 | Classified by FDA | +47 days |
| 5 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Where it was distributed
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
Questions about this recall
Why was it recalled?
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Which lots are affected?
Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
Where was it sold?
Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
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.
More recalls from United Orthopedic
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral valgus offset adaptor, left recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | Ustar II Knee System Hinge Box Trial, L, #1 recalled | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System PSA Box Trial, L, #1 recalled by United Orthopedic | United Orthopedic | Device Malfunction | Nationwide |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | 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 | Device Malfunction | 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) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |