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Zimmer Biomet Comprehensive Reverse Shoulder device; image courtesy of www.fda.gov.

A recall of the Zimmer Biomet Comprehensive Reverse Shoulder device was recently issued due to a higher rate of fractures than is described on the label. The FDA has stated that this is a Class I recall. This level of recall is the most serious possible, as use of the affected devices could cause serious injuries, including death.

Zimmer Biomet’s Comprehensive Reverse Shoulder is a surgically implantable medical device that helps patients recover arm movement. It’s especially helpful for those with torn rotator cuffs who have severe shoulder arthritis along with a previously failed shoulder joint replacement.

Healthy shoulder (left); arthritic shoulder (right); image courtesy of www.biomet.co.uk.
Healthy shoulder (left); arthritic shoulder (right); image courtesy of www.biomet.co.uk.

Unfortunately, Zimmer Biomet discovered that the Comprehensive Reverse Shoulder devices have a higher rate of fractures than is described on the label. If the device fractures, patients may need revisions surgeries. Such surgeries carry the risk of serious health issues, including infection, permanent loss of shoulder function and, in rare cases, death.

The company issued an Urgent Medical Device Recall Notice along with a Certificate of Acknowledgement form to affected consumers. The recall covers the following:

  • The Comprehensive Reverse Shoulder System Humeral Tray Model 115340, known by the trade name Biomet Comprehensive Reverse Shoulder Humeral;
  • Product codes KWS and PAO;
  • A total of 3,662 devices that were manufactured from August 25, 2008 to September 27, 2011 and distributed from October, 2008 to September, 2015;
  • All lots with the part number 115340 (a full list of lot numbers appears at the end of this article).

The notice and form were sent on December 20, 2016. The notice, in addition to listing recalled product, also asked consumers to do the following:

  • Read the safety notice and advise all appropriate staff;
  • Identify and quarantine all affected devices that have not yet been implanted;
  • Hold the devices for removal by a Zimmer Biomet sales representative;
  • Fill out and send the Certificate of Acknowledgement via email within three days to postmarket@zimmerbiomet.com;
  • Keep a copy of the Certificate of Acknowledgement form in the consumers’ records as supporting documentation if there is ever a compliance audit.

Regarding recalled devices that have been implanted, the company advised health care providers that no specific patient monitoring was needed beyond normal existing protocols for surgical follow ups.

All consumers (health care providers and patients) who have questions are encouraged to contact Zimmer Biomet’s 411 Technical Services at 574-371-3071 or via email at corporatequality.postmarket@zimmerbiomet.com.

Adverse reactions or other quality issues related to the Comprehensive Reverse Shoulder should be reported to MedWatch, the FDA’s Safety Information and Adverse Even Reporting program. This can be done either online at www.fda.gov/MedWatch/report or via FAX to 1-800-FDA-0178.

Here are the affected lot numbers:

041870 041880 041890 052860 060500 070330 079900 085130 118250 118260 118270 118280 118290 118300 118340 118350 118360 118370 118380 118390 132020 132030 153330 153340 153350 153360 153370 153380 153390 153400 153410 153420 153430 159650 159660 161960 172670 215990 216000 216010 256990 257000 257010 257020 278300 278310 278320 278330 278550 278560 278580 278590 300090 300100 300110 300120 300130 300140 300150 310580 310590 310600 310610 310620 329390 349140 349150 351030 351040 367300 367310 367320 367330 367340 367350 367360 367370 367380 372290 372310 372320 385090 402880 411980 413530 415040 415050 415060 415070 415080 415090 420630 424640 424650 424660 424670 424680 424690 424700 424710 424720 424730 424740 436760 436770 440500 457900 492370 492380 492390 492400 492410 492420 492430 492440 492450 501830 551660 556800 556820 557440 557620 557840 558840 558880 558890 558900 558910 558920 561910 562430 563440 568870 569050 569060 569070 569080 569090 569100 569120 569130 569140 569150 569690 578920 595090 597740 607390 607400 607410 607420 607430 609780 613990 630660 633600 634660 634860 635190 637190 637240 641220 641350 641390 641680 648790 648800 648810 648820 648830 648860 659950 659960 659970 659980 659990 660000 660010 660020 660030 660040 668550 668560 668570 668580 668590 668600 668610 668620 668630 668970 674320 677090 677100 677110 677140 677150 677160 677170 677180 677190 677200 680720 680730 680740 680750 680760 697100 697110 697120 697130 697150 697160 697170 697180 697190 697200 704050 704810 706840 712090 715990 716200 723830 723850 723870 723880 725550 725560 725760 726590 726710 734810 745350 762930 764700 765560 765830 765870 767360 767370 771810 788670 788680 788690 791260 791270 791280 818790 839150 846190 846200 846210 846230 846240 846280 846290 846300 846310 846320 846330 848110 848120 848130 848140 848150 848160 848170 848190 848200 848210 848220 848230 848240 848250 848260 848270 848280 848290 848300 848310 848320 854210 854220 854240 854250 854260 854290 854300 854310 854320 863330 889690 908010 950390 950400 963700 974990 981260 981270

Sources:

Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall – High Fracture Rate

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