FDA (Devices) recall action 77141

Zimmer Biomet, Inc. recalled 8 products on 2017-06-21

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2017-06-21
Critical: 0
Units: 60,352

Why these products were recalled

Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Tibial Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling sterile tibial intramedullary nails because packaging design verification tests failed. The action affects 1,499 units distributed domestically and internationally.
Product
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Sterile Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 87 units of sterile implants because packaging design verification tests failed. The action covers domestic and international distribution.
Product
4.5 BROAD SCP PLT 26-H STER
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 445 units of sterile-packaged VERSA-FXII SC TUBE PLT implants due to packaging design verification test failures.
Product
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Sterile-Implant Tubes Due to Packaging Design Failures
Zimmer Biomet is recalling 510 units of sterile-packaged VERSA-FX II STD TUBE implants because packaging design verification tests failed.
Product
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Z Nail Implants Due to Packaging Design Failures
Zimmer Biomet is recalling 1,707 sterile Z Nail implants because packaging design verification tests failed. The action covers domestic and foreign distribution.
Product
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Sterile-Packaged Femoral Intramedullary Nails
Zimmer Biomet is recalling sterile-packaged femoral intramedullary nails due to packaging design verification test failures.
Product
FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15M
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls R-F IM Nails Due to Packaging Design Failures
Zimmer Biomet is recalling 3,856 sterile-packaged R-F IM Nails because packaging design verification tests failed. The action covers units distributed domestically and internationally.
Product
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
Category
Distribution
50 states
ModerateFDA (Devices)··2017-06-21
Zimmer Biomet Recalls Sterile-Packaged Femoral Intramedullary Nails
Zimmer Biomet is recalling sterile-packaged femoral intramedullary nails due to packaging design verification test failures.
Product
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MM
Category
Distribution
50 states