Recall archive / FDA device enforcement
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile — FDA record Z-0453-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
- 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.
- Classification
- Class II
- Recalling firm
- Medshape, INC.
- Quantity
- 26 units (1 count)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0453-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 12, 2022
- Recall initiation date
- Nov 17, 2021
- Center classification date
- Jan 4, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.