Agency classClass IIOur severity:High FDA (Devices)·Z-0622-2016·Announced 2016-01-20

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.

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 3/5 (High).

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…
Manufacturer: OrthoPediatrics Corp
Category: Medical Device — Orthopedic Implants
Hazard: manufacturing-defect
device-malfunction
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

Distributed in 20 states:

Same manufacturer · OrthoPediatrics Corp

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Same hazard · manufacturing defect