Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
- Recall Initiated
- July 30, 2021
- Terminated
- December 15, 2021
- Recall Number
- Z-2488-2021
- Quantity
- 14 drill bits
Reason for Recall
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.
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 / Code Info
Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550
Root Cause
Process change control
Action Taken
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