CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report
Slipped Capital Femoral Epiphysis recalled by Pega Medical
Pega Medical is recalling Slipped Capital Femoral Epiphysis (Scfe) Drivers of the Free-Gliding Scfe Screw System, distributed in Florida, Tennessee. The recall was initiated on 15 Jun 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-1848-2015
- FDA event ID
- 71560
- Recalling firm
- Pega Medical, Laval
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jun 2015
- FDA classified
- 26 Jun 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 15 Jun 2015 | Recall initiated by company | |
| 26 Jun 2015 | Classified by FDA | +11 days |
| 8 Jul 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Product as listed by the FDA
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Where it was distributed
US Distribution to the states of : FL and TN.
Questions about this recall
Why was it recalled?
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Which lots are affected?
Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.
Where was it sold?
US Distribution to the states of : FL and TN.
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 Pega Medical
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Orthopedic manual Surgical Instrument handle recalled by Pega Medical | Pega Medical | Device Malfunction | Nationwide |
| Device | CLASS II | SCFE (slipped capital femoral epiphysis) Knobs recalled by Pega Medical | Pega Medical | Other | Nationwide |
| Device | CLASS II | SLIM Handle recalled by Pega Medical | Pega Medical | Other | 8 states |
| Device | CLASS II | Scfe Driver (Scf-MLD273 & Scf-MLD265) instrument used recalled | Pega Medical | Other | FL, TN |
| Device | CLASS II | Female Driver recalled by Pega Medical | Pega Medical | Device Malfunction | 4 states |
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 |