FDA-Device2022-01-12Class II
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medshape, INC.
Hazard
The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.
Sold states
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Affected count
26 units (1 count)
Manufactured in
1575 Northside Dr Nw Ste 440, N/A, Atlanta, GA, United States
Products
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2022Don't want to check this manually?
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