FDA-Device2022-03-09Class II

Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

ROi CPS LLC
Hazard

Products are mislabeled with the incorrect product identification on individual kit labeling.

Sold states
Missouri
Affected count
50 kits
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2022

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