OrthoPediatrics Corp: Medical Device Recall in 2020 - (Recall #: Z-2742-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 6, 2020

Date Posted: August 5, 2020

Recall Number: Z-2742-2020

Event ID: 86027

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

Status: Ongoing

Product Quantity: 73 units

Code Information:

Lot Number: 108332-A UDI: (01)0084113212400(10)108332A

Distribution Pattern:

US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.

Voluntary or Mandated:

Voluntary: Firm initiated