medical Class II Updated 2020-12-23

Biomet, Inc. recalls Comprehensive Reverse Shoulder System, Item numbers 115394,

Recalled Product

Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Hazard / Issue

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots 208000 270240 270260 208010 214760 270290 270300 270310 484060 484150 208130 155060 208270 472020 193140 193200 193220 193300 272150 272290 354260 354350 497880 497910 497930 497970 498680 498690 498700 509140 214470 214490 214500 214520 154290 154300 154360 272530 498790 498800 498860 498870 154420 154430 214610 272620 272680 354050 354090 354110 354120 354130 354150 498880 498890 498910 498920 498940 498960 214630 214640 214650 272730 376710 625850 214660 353570 272770 272840 353600 499060 625860 625870 625880 625900 214700 351300 352990 353620 353650 214710 214720 214730 353230 353240 353270 353280 353300 214740 272920 353310 353340 353350 214750 353370
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