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.
What this means for you
Illness, injury, or structural failure has been reported. 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
Related recalls
Same manufacturer · OrthoPediatrics Corp
See all →- HighOrthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22
- HighExternal Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
FDA (Devices) · 2022-09-14
- SevereOrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk
FDA (Devices) · 2020-08-05
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
- ModerateOrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15