OrthoPediatrics Recalls Response BandLoc Tensioner Instruments Due to Band Rupture Risk
OrthoPediatrics Corp is recalling 82 Response BandLoc 5.5/6.0 Tensioner Instruments because over-tensioning can damage the band, causing it to rupture during spine 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for significant injury or structural defect in a medical device are categorized as Severe (Score 4).
Plain-English summary
OrthoPediatrics Corp is recalling 82 units of the Response BandLoc 5.5/6.0 Tensioner Instrument (Product Number 01-1102-1000). This medical device is used by surgeons to apply recommended tension to a band and hold it in place during spine manipulation and set screw tightening.
The recall was initiated because over-tensioning of the band can result in damage to the band, causing it to rupture. The agency has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The affected units were distributed worldwide, including to the United States (Missouri, New York, Kentucky, Florida, North Carolina, and Ohio) and to Australia, France, and Spain. Healthcare providers and patients who have used this instrument should contact OrthoPediatrics Corp for further instructions on how to proceed.
The recalled product
- Product
- Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 82
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)
- All lots Product Number: 01-1102-1000
Distribution
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