Z-0622-2016Class II

UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for...

Name: Z-0622-2016 UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for...
Creator: OrthoPediatrics Corp
Published: 2015-11-10
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2015-11-10 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior... on 2015-11-10. FDA classified it as Class II and gives the reason as "Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0622-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-10
Posted: 2016-01-08
Terminated: 2016-05-23
Recalling firm: Orthopediatrics Corp
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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: The firm, OrthoPediatrics Corp., sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/13/2015 to affected customers via email. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and actions to be taken. The customers were instructed to take immediate possession of all the identified devices; quarantine them and immediately return them to OrthoPediatrics, and complete and return the Mandatory Reply Form via fax to (574) 269-3692 or email: [email protected]. If you have any questions, please contact VP-Regulatory Affairs (574) 268-6379 or email: [email protected].
Quantity in commerce: 102
Distribution: US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.
Product codes and lots: 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; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 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; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM. 00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0622-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0622-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-08

Product code NKB

K150600Class IIResponse 5.5/6.0 Spine SystemOrthoPediatrics Corp. / cleared 2015-05-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)