FDAClass IIJanuary 12, 2022

Dynanail Mini recall

DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

Why was Dynanail Mini recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060

Product
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Recalling firm
Medshape, INC.
Quantity
26 units (1 count)
Distribution
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Recall date
January 12, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls