Product Safety Recalls

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Medshape, INC. Recall 89117

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

Medshape, INC. Recall 89117 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0453-2022
Event ID89117
Event DescriptionDYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Product TypeDevices
DistributionDomestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
Quantity26 units (1 count)
Recall ReasonThe 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.
Device Classification20220112
Device Code InfoModel No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
Center Classification Date20220104
Recall Initiation Date20211117
Recalling FirmMedshape, INC.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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