Z-2742-2020 Class II Ongoing
FDA device recall Z-2742-2020 was initiated by OrthoPediatrics Corp on July 6, 2020 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 73 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- July 6, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units
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
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
Distribution Pattern
US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
Code Information
Lot Number: 108332-A UDI: (01)0084113212400(10)108332A