Zimmer Biomet, Inc.: VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

Is my product affected?

VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

• UPC 00119309016
• UPC 00119309516
• UPC 00119309518
• UPC 00119309520
• UPC 00119309522

Check against the official notice below — it lists the full affected range.

What happened

Zimmer Biomet is recalling 445 VERSA-FXII SC TUBE PLT sterile-packaged implants in various sizes due to packaging design verification test failures. The affected implants were distributed across the United States (including Puerto Rico and Alaska), Canada, and numerous countries in Europe, the Middle East, Africa, Asia, and Central America. The specific lot numbers and item numbers are documented in the recall notice for identification purposes.

The source does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Distribution: Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON Quantity: 445 Lot/code info: I10K: K954555,K150818 Item Numbers: 00119309016, 00119309516, 00119309518, 00119309520, 00119309522; Lot Numbers: 60746132 60746132R 60699481 60699481R 60812398 60812398R 60844072 60844072R 60820576 60868450 368893 368898 368898R 368917 368916 368899 61577082 61989416 370907 61895937 61895939 371034 62279718 62351559 62445941 62445942 62511278 62539606 37214360 37214354 37214361 37109128 37109081 62931489 62931529 62930529 63009490 63079560 63564928 63594628

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.2017-04-28
• VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H2017-04-28
• 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 LG2017-04-28
• 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 15MMDX38CM FEM IM NAIL 11MMDX40CM 2017-04-28
• 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 TIBIAL I/M NAIL 15MMDX38CM TI2017-04-28

All FDA (Device enforcement) recalls