Medshape, INC. Recall 89117
Description: DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medshape, INC. Recall 89117 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0453-2022 |
| Event ID | 89117 |
| Event Description | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile |
| Product Type | Devices |
| Distribution | Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA. |
| Quantity | 26 units (1 count) |
| Recall 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. |
| Device Classification | 20220112 |
| Device Code Info | Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060 |
| Center Classification Date | 20220104 |
| Recall Initiation Date | 20211117 |
| Recalling Firm | Medshape, INC. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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