FDA Medical Device Recalls (openFDA)
Medshape, INC.: DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
- Recall number
- Z-0453-2022
- Recalling firm
- Medshape, INC.
- Product
- DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
- Status
- Open, Classified
- Initiated
- 2021-11-17
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- The firm indicated that they will send recall notification to sales representatives via email or certified mail. Customers will be instructed to remove all +6 mm endcaps from stock and to return to the recalling firm with a return label that will be provided at a later date. Customers with questions are to contact the recalling firm at (678)235-3314.
- Quantity
- 26 units (1 count)
- Distribution
- Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.
- Lot, serial or model codes
- Model No. 2600-05-006; Lot No. 04882; UDI: M97026000500060
- 510(k) numbers
- ["K203381"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3007593722
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28