FDA Medical Device Recalls (openFDA)
Paragon 28, Inc.: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
- Recall number
- Z-2488-2021
- Recalling firm
- Paragon 28, Inc.
- Product
- Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
- Status
- Terminated
- Initiated
- 2021-07-30
- Posted
- not on file
- Terminated
- 2021-12-15
- Reason
- A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
- Root cause
- Process change control
- Action
- On 08/12/2021, the Recalling Firm emailed to its distributors an "Medical Device Recall" Notification Letter inform them that it was identified that there is a thin wall condition between the inner cannulation and the flutes of the drill. At worst case, the defect is a fracture through the wall of the drill to the cannulation beneath. This feature is potentially nonconforming in some units within the lot identified below. The distributor was instructed to: 1) Immediately check its inventory and hospitals/health care facility within their region and to identify, discontinue use, quarantine and not distribute any further the affected products. 2) Complete the Medical Device Recall Response Form and return to mkinnee@paragon28.com. The form is to be completed and returned even if no physical product is in their possession. 3) Immediately return affected devices along with a copy of the Medical Device Recall Response Form to the Recalling Firm at Paragon28, Attn: Recalls, RN-008, 14445 Grasslands Dr., Englewood, CO 80112. For questions or further assistance - contact the Recalling Firm at: email - mkinnee@paragon28.com or complaints@paragon28.com Phone - 949-280-7688
- Quantity
- 14 drill bits
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A
- Lot, serial or model codes
- Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3008650117
- Firm city
- Englewood
- Firm state
- CO
- 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