FDA Device recall Z-0453-2022
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
- FDA Device
- Class II
- ongoing
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile by Medshape, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0453-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-17 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medshape |
| Distribution | CA, FL, GA, IL, IN, MA, MD, TX, WA |
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.
Identifiers
| code_info | Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0453-2022%22
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