FDAFDA · Food and drugs·Recall number Z-2742-2020
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
Published August 5, 2020 · Recall initiated: July 6, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
- Lot
- Lot Number: 108332-A UDI: (01)0084113212400(10)108332A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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