FDA Device Intelligence
Home › NEWDEAL › PANTA

PANTA

NEWDEAL · Model 501027ND · UDI-DI 10381780050643

HSB Prescription
1
510(k) clearances
37,998
Adverse events (115 deaths)
690
Recalls
303
Facilities

Description

Bony fixation of Panta nail is achieved using two tibial screws, two calcaneal screws and one talar screw. Holes in the nail allow for proximal and distal locking, using locking cortical screws (fully threaded or partially threaded) 5 mm diameter, from 20 to 110 mm length.

Recalls

DateFirmReason
2026-03-16Smith & Nephew, Inc.Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ
2025-12-02Zimmer, Inc.Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occ

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.