Z-0597-2018Class II

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw

Name: Z-0597-2018 Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw
Creator: OrthoPediatrics Corp
Published: 2017-08-03
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2017-08-03 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation on 2017-08-03. FDA classified it as Class II and gives the reason as "The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws". 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-0597-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-03
Posted: 2018-02-14
Terminated: 2019-05-08
Recalling firm: Orthopediatrics Corp
Product: Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Product code: OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Reason for recall: The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to [email protected] or calling (574) 268-3692
Quantity in commerce: 24 units
Distribution: US Nationwide Distribution
Product codes and lots: Model number: 00-1300-0740, Lot number: M82791-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0597-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0597-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-13

Product code OSH

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)