Pega Medical Recalls SCFE Knobs for Driver Due to Screw Loosening Risk
Pega Medical Inc. is recalling 31 SCFE Knobs for Driver because screws may loosen during ultrasonic cleaning and fall out.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a potential mechanical defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Pega Medical Inc. is recalling 31 units of SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm. These are orthopedic surgical instrument components used for hip surgery. The recall covers specific catalogue numbers (SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373) and lot numbers (160428-03, 160428-04, A182-05, A182-15, 160603-05, 160603-06, A183-06).
The recall was initiated because there is a potential for the screws to become loosened during ultrasonic cleaning of the knobs, which may cause the screws to come out. This is classified as an FDA Class II recall.
The devices were distributed nationwide to California, Florida, Georgia, Hawaii, Louisiana, Massachusetts, Missouri, North Carolina, New York, and Oklahoma. They were also distributed internationally to Australia, Canada, Denmark, Germany, Israel, Mexico, Romania, Russia, the United Arab Emirates, and the United Kingdom. Healthcare facilities should stop using these devices and contact the manufacturer for instructions.
The recalled product
- Product
- SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
- Manufacturer
- Pega Medical Inc.
- Hazard
- Affected units
- 31
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distribution
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