SCFE (slipped capital femoral epiphysis) Knobs for recall
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Why was SCFE (slipped capital femoral epiphysis) Knobs for recalled?
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Numbers: SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373; Lot Numbers: 160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06
- Product
- SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
- Recalling firm
- Pega Medical Inc.
- 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
- Recall date
- November 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)