FDA Device recall Z-1236-2018

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inse…

FDA Device
Class II
terminated
Published 2018-04-04

On 2018-04-04 the FDA classified a Class II recall of Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inse… by Zimmer Biomet, citing certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1236-2018
Classification	Class II
Status	terminated
Initiated	2018-03-12
Published	2018-04-04
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Biomet
Distribution	US

Product

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

Reason

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

Identifiers

code_info	Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020… Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020 508030 508070 508080 484940 485380 485410 485420 485430 485440 485450 485460 535050 623990 636950 636960 636970 636980 636990 676570 676600 676610 676620 676630 676640 928320 928340 928370 928380 090570 484120 484230 484300 484320 484330 484370 484420 484440 484450 484490 526200 526210 526230 526250 526260 526270 526280 526290 526300 598480 599230 599240 599250 599260 599270 658950 658980 658990 659000 659010 659020 676710 677010 677030 677040 697990 698710 721000 721360 721380 721390 721400 721410 721420 721440 625110 079640 508410 508450 508460 508470 508480 508490 508510 508520 508500 457030 073530 073540 073550 073560 073570 073580 073590 073600 073610 627490 656470 656580 656590 656600 656610 656620 656640 656660 966880 967050 967060 967070 980260 980270

code_info

Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020…

Lots manufactured before March 30, 2017. Packaging Lot Numbers: 303420 301890 507880 507930 507980 508010 508020 508030 508070 508080 484940 485380 485410 485420 485430 485440 485450 485460 535050 623990 636950 636960 636970 636980 636990 676570 676600 676610 676620 676630 676640 928320 928340 928370 928380 090570 484120 484230 484300 484320 484330 484370 484420 484440 484450 484490 526200 526210 526230 526250 526260 526270 526280 526290 526300 598480 599230 599240 599250 599260 599270 658950 658980 658990 659000 659010 659020 676710 677010 677030 677040 697990 698710 721000 721360 721380 721390 721400 721410 721420 721440 625110 079640 508410 508450 508460 508470 508480 508490 508510 508520 508500 457030 073530 073540 073550 073560 073570 073580 073590 073600 073610 627490 656470 656580 656590 656600 656610 656620 656640 656660 966880 967050 967060 967070 980260 980270

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1236-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.