Recall Z-0270-2020 ยท LXH Orthopedic Manual Surgical Instrument
Pega Medical Inc.
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
| Date | Oct 2, 2019 |
| Status | Terminated |
| Reason | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. |
| Root cause | Device Design |
| Action | Pega Medical notified customers of the recall on about 10/02/2019, via "Urgent Field Safety Notice - Recall" letter. Customers were informed that SCFE Drivers, 6.5mm and 7.3 mm of the Free Gliding SCFE Screw System had issues with the knobs. Specifically the knobs have the potential to have loosened screws, or screws that have fallen out, as a result of the ultrasonic cleaning of the knobs. Customers were instructed to identify affected devices in inventory and return them to Pega Medical as soon as possible to address the issue. There returned devices can be returned via the FedEx infor |
| Quantity | 31 devices |
| Distribution | Nationwide distribution to CA, FL, GA, HI, LA, MA, MO, NC, NY, OK. International distribution to AUSTRALIA, CANADA, DENMARK, GERMANY, ISRAEL, MEXICO, ROMANIA, RUSSIA, UNITED ARAB EMIRATES, UNITED KINGDOM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.