RecallDepth

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

Company
Medshape, Inc.
Recall Initiated
November 17, 2021
Recall Number
Z-0453-2022
Quantity
26 units (1 count)
Firm Location
Atlanta, GA

Reason for Recall

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.

Distribution

Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.

Lot / Code Info

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

Root Cause

Device Design

Action Taken

The firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314.

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