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Open, Classified

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

FDA Recall Z-0453-2022 · Posted None

Recalling FirmMedshape, INC.
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2021-11-17
Product Quantity26 units (1 count)

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.

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K203381Dynanail Mini HybridMedShape, Inc. · 2021-01-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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