Synthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk
Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.
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 involves a structural defect in a medical device that may result in mechanical failure, requiring surgery and potentially causing soft tissue or visceral injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
Synthes (USA) Products LLC is recalling 3,262 units of VEPTR Vertical Expandable Prosthetic Titanium Rib inferior cradles, also known as caudal rib supports. These devices are used to mechanically stabilize or correct thoracic deformities to allow chest and lung growth. The recall covers specific part numbers and lot numbers distributed worldwide, including the United States, Canada, and Germany.
The recall is issued because the last hole on certain inferior cradles may be partially formed. Fully lengthening the construct to this partially formed hole may result in mechanical failure due to rib sleeve breakage. This failure may require surgery to exchange components and could result in pain, loss of deformity correction, and/or soft tissue or visceral injury.
Healthcare providers and patients should contact Synthes (USA) Products LLC for instructions on how to manage the affected devices. The source text does not specify a particular action for consumers to take other than the potential need for surgical intervention if the device fails.
The recalled product
- Product
- VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 3,262
Distribution
Distributed nationwide across the United States.
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