Pega Medical Recalls GAP Nail 4.8mm Due to Distal Screw Hole Failures
Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail because of failures at the distal cortical screw holes, primarily in patients with specific bone conditions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly identifies device failures in patients, which aligns with the rubric criterion for Severe severity involving significant injury or structural defects.
Plain-English summary
Pega Medical Inc. is recalling 7 units of the 4.8mm GAP Nail, part of the GAP Endo-Exo Medullary System. The affected catalog numbers are GAP-N48-16, GAP-N48-18, GAP-N48-26, and GAP-N48-28. The specific lot numbers involved are 110913-001, 110913-002, 110913-004, and 110913-005.
The recall was initiated because failures were identified at the level of the distal cortical screw holes. These failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates were also detected in tibias with distal fractures located close to the distal locking holes.
The affected devices were distributed nationwide in the United States, specifically in California, Florida, New York, and Puerto Rico. The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia, and humerus of pediatric patients who have reached skeletal maturity.
The recalled product
- Product
- GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and…
- Manufacturer
- Pega Medical Inc.
- Hazard
- Affected units
- 7
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 (4)
- Lot numbers: 110913-001
- 110913-002
- 110913-004
- 110913-005
Distribution
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