Home / Recalls / Medshape, INC. / Z-0453-2022

Z-0453-2022 Class II Ongoing

Recalled by Medshape, INC. — Atlanta, GA

Recall Details

Product Type: Devices
Report Date: January 12, 2022
Initiation Date: November 17, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 26 units (1 count)

Product Description

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

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 Pattern

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

Code Information

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