Class II — Medshape, INC.
| Recalling firm | MedShape, Incorporated |
|---|---|
| Registered facility | MEDSHAPE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile |
| Quantity | 26 units (1 count) |
| Distribution | Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA. |
| Initiated | 2021-11-17 |
| Classified | 2022-01-04 |
| Recall number | Z-0453-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medshape, INC. (Z-0453-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89117/
Alerts for MedShape, Incorporated
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.