Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1859-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement

Product Classification:

Class II

Date Initiated: February 17, 2017

Date Posted: April 26, 2017

Recall Number: Z-1859-2017

Event ID: 76507

Reason for Recall:

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

Status: Terminated

Product Quantity: 28,253 in total

Code Information:

Items and lots: Item 113870 361800 Item 113951 605610 684300 684310 684320 684330 684340 Item 113952 174480 241520 292440 292480 372590 372600 372610 372620 372630 372640 596930 596940 596950 596960 605640 605650 605670 Item 113954 174560 241500 270220 270230 292490 292510 292520 292560 292570 372650 372660 372670 372680 372700 372710 596970 596980 596990 605680 605690 605700 605710 707650 Item 113956 292580 292590 292640 605720 605730 605740 Item 114827 804070 Item EP-115393 488700 488710 577700 577710 667420 667430 667460 Item EP-115394 488750 577740 Item EP-115395 577760 Item EP-115396 488760 577770 Item EP-115398 832600 Item PM555411 430360 Item XL-115363 169490 179400 488780 488790 488810 488830 488850 488870 488890 488900 488910 488920 515590 560180 560210 667480 667490 667500 667510 744780 744810 773080 Item XL-115364 542280 542290 744850 744870 Item XL-115366 502530 502540 502560 614450 666000 Item XL-115367 630520

Distribution Pattern:

Worldwide - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND UK

Voluntary or Mandated:

Voluntary: Firm initiated