OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect in a spinal implant represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
OrthoPediatrics Corp is recalling 102 units of the Response 5.5/6.0 Spine System, specifically the UniAxial Pedicle Screw and UniAxial Reduction Pedicle Screw. The recall was initiated because the devices may have been manufactured incorrectly, which prevents the driver from fully engaging into the hexagonal drive feature of the screw.
The affected products were distributed in the United States to the states of Alabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Kentucky, Louisiana, Michigan, Missouri, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee, and Texas. The specific item numbers, lot numbers, and product descriptions for the affected units are listed in the structured product information.
Healthcare providers and patients should stop using the affected devices and contact OrthoPediatrics Corp for further instructions on how to proceed with the recall.
The recalled product
- Product
- UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw 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 d
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 102
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 (20)
- Item number
- lot
- product description 00-1300-1735
- 44003
- 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM. 00-1300-0735
- 44601
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM. 00-1300-0740
- 44602
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740
- 43926
- 44252
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0745
- 43927
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM. 00-1300-0750
- 44619
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM. 00-1300-0620
- 44623
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM. 00-1300-0640
- 44617
- 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-0640
Distribution
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