Z-2742-2020Class II

Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for...

Name: Z-2742-2020 Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for...
Creator: OrthoPediatrics Corp
Published: 2020-07-06
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2020-07-06 / Open, Classified

FDA source

OrthoPediatrics Corp began a recall of 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... on 2020-07-06. FDA classified it as Class II and gives the reason as "Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2742-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-06
Posted: 2020-07-30
Recalling firm: Orthopediatrics Corp
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 disease Model Number: 00-1300-6053
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
FDA root cause: Under Investigation by firm
Action: Orthopedics issued Field Action Notice distributed via email on July 6, 2002 stating reason for recall , heath risk and action to take: Distributors are required, to perform sub-recall. The affected product must be returned to OrthoPediatrics Corporation. Replacement product will be provided. Please contact customer service to arrange return of the affected product. Distributors should retrieve affected product that may be with customers. No additional corrective actions need to be taken for product already implanted. Please complete and return the attached response form confirming your understanding of these instructions. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897
Quantity in commerce: 73 units
Distribution: US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
Product codes and lots: Lot Number: 108332-A UDI: (01)0084113212400(10)108332A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2742-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2742-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-08-05	2020-07-30

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)