OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk
OrthoPediatrics Corp is recalling 73 units of 6.0MM spine rods because incorrect laser etching may compromise strength and lead to unintended fracture.
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 lead to unintended fracture, which aligns with the rubric criteria for a Severe (4) rating involving significant injury risk or structural defects.
Plain-English summary
OrthoPediatrics Corp is recalling 73 units of the Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH (Model Number: 00-1300-6053). This product is part of the RESPONSE 5.5/6.0 Spine System, which is intended for the immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for degenerative disc disease.
The recall was initiated because the product may have incorrect laser-etched alignment lines. The non-conforming laser etch may have compromised the strength of the device, potentially leading to unintended fracture.
The affected units are identified by Lot Number 108332-A and UDI (01)0084113212400(10)108332A. These products were distributed nationwide in the United States, including in the states of Alabama, California, Florida, Georgia, Kentucky, Michigan, Missouri, North Carolina, New York, Ohio, and Texas. Healthcare providers and patients should contact OrthoPediatrics Corp for further instructions regarding the recall.
The recalled product
- Product
- Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc…
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 73
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 Number: 108332-A UDI: (01)0084113212400(10)108332A
Distribution
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