Recall Z-2742-2020
OrthoPediatrics Corp · initiated July 6, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number: 108332-A UDI: (01)0084113212400(10)108332A
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-determined cause: Under Investigation by firm
Action taken
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 kanderson@orthopediatrics.com or 574-267-0897
Details
- Recall number
- Z-2742-2020
- Initiated
- July 6, 2020
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 73 units
- Distribution
- US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN