FDA Device recall Z-1861-2017

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee Syste…

FDA Device
Class II
terminated
Published 2017-04-26

On 2017-04-26 the FDA classified a Class II recall of various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee Syste… by Zimmer Biomet, citing endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1861-2017
Classification	Class II
Status	terminated
Initiated	2017-02-17
Published	2017-04-26
Last updated	2026-09-13 11:54 UTC
Company	Zimmer Biomet
Distribution	US

Product

various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

Reason

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

Identifiers

code_info	Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 46… Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 780710 780720 780730 780750 780760 Item 150478 240650 576750 576760 576770 576780 Item 159540 347930 373920 373940 456340 456350 545520 545530 Item 159541 341160 347940 347950 456370 456380 Item 159542 373970 442290 528600 Item 159543 293050 444990 Item

code_info

Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 46…

Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 780710 780720 780730 780750 780760 Item 150478 240650 576750 576760 576770 576780 Item 159540 347930 373920 373940 456340 456350 545520 545530 Item 159541 341160 347940 347950 456370 456380 Item 159542 373970 442290 528600 Item 159543 293050 444990 Item

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-1861-2017%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.