Pega Medical Recalls Female Driver Instruments for Orthopedic Procedures
Pega Medical Inc. is recalling 9 Female Driver instruments used in orthopedic procedures because the hexagonal tip is 0.06 mm under specifications, which may lead to breakage.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect that could lead to tip breakage during a procedure. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pega Medical Inc. is voluntarily recalling 9 units of the Female Driver instrument, part number FDr101, used for the insertion of the Fassier-Duval IM Telescopic System. This instrument is intended for orthopedic procedures and is included in the Fassier-Duval IM Telescopic System instrument tray. The specific lot number is 290609-01.
The recall is being conducted because the hexagonal tip of the instrument is 0.06 mm under the required specifications. This deviation may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage during use.
The affected units were distributed worldwide. In the United States, 5 units were distributed in Delaware, Florida, Nebraska, and New York. The remaining 4 units were distributed internationally in Australia, Brazil, and the United Kingdom. Healthcare facilities and users should stop using the affected instruments and contact Pega Medical Inc. for further instructions.
The recalled product
- Product
- Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue…
- Manufacturer
- Pega Medical Inc.
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 (1)
- Lot 290609-01
Distribution
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