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Recall Observatory FDA recall evidence

Device product

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

Z-0453-2022

November 17, 2021

Class II

Product summary

Firm
Medshape, INC.
Event
Event 89117
Status
Ongoing
Classification
Class II
Quantity
26 units (1 count)
Official record key
device-enforcement:Z-0453-2022

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.