FDA Medical Device Recalls (openFDA)
Medshape, INC.: Medshape Universal Joints, REF: DNE-9000-UJ
- Recall number
- Z-2513-2025
- Recalling firm
- Medshape, INC.
- Product
- Medshape Universal Joints, REF: DNE-9000-UJ
- Status
- Open, Classified
- Initiated
- 2025-06-02
- Posted
- 2025-09-03
- Terminated
- not on file
- Reason
- Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
- Root cause
- Process control
- Action
- On 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to FAsalessupport@enovis.com If you have any questions, contact firm at productsafety@enovis.com
- Quantity
- 849
- Distribution
- US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA.
- Lot, serial or model codes
- UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
- 510(k) numbers
- ["K151580"]
- PMA numbers
- not on file
- Product code
- KTT
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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