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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Zimmer Biomet, Inc.: The set screw is not able to advance or reverse from the original position in the nail.

Agency Publication Date: September 13, 2018
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Affected Products

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280

331370 500240

Product: Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180

017090 017100 017110 017120 063130 063190 188050 188080 188090 219720 219730 219740 219750 290520 290550 331360 371020 371060 455870 455890 530040 530060 530080 541100 559250 559260 559270 559290 688160 706780 899800 944420 530030 530090

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300

017130 052890 052910

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 320 mm, Item Number: 814309320

789980

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360

050830 052950 417420

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380

814250

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm, Item Number: 814309420

151830 886880

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440

814090 899810

Product: Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460

097120 767700

Product: Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180

017190 017200 017210 017240 017260 063270 063330 063360 063370 063400 087850 087870 097080 132740 153330 153470 153490 153510 153540 219770 219780 290570 290580 290620 500680 500710 500740 503300 503350 519650 565790 565800 585690 601380 628190 645550 645580 688170 688190 688200 688210 707670 741680 741690 741700 899820 899840 899850 899870 899880 900000

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 280 mm, Item Number: 814311280

500770 790170

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 300 mm, Item Number: 814311300

132800

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320

900040

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 340 mm, Item Number: 814311340

152960 331460 456050 944450

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 360 mm, Item Number: 814311360

132900 150870 331470 773070 688290

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380

132920 188120 331480 688320 814070

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 400 mm, Item Number: 814311400

097130 245980 417450 519300 854260 645620 645650

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 420 mm, Item Number: 814311420

060900 331520 417460 645670 688350 017270

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440

050850 155250 500840 541270 559240

Product: Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 460 mm, Item Number: 814311460

017290 063450 155220 500860

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180

060870 063550 063560 063570 114480 645700 900100 900250 944470 500880

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 260 mm, Item Number: 814313260

053670 813260

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm, Item Number: 814313280

053750 813300

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 300 mm, Item Number: 814313300

645720

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 320 mm, Item Number: 814313320

331530 971020

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340

133040 188240 645750

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 360 mm, Item Number: 814313360

050870 501210 645770

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 380 mm, Item Number: 814313380

482620 501270 813390

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400

501350

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 420 mm,Item Number: 814313420

017300 097020 559190

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 440 mm, Item Number: 814313440

155200 502270 051080

Product: Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 460 mm, Item Number: 814313460

083760 017310

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 260 mm, Item Number: 814409260

971030

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 280 mm, Item Number: 814409280

707700

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300

133160 790790

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320

114560 133170

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 340 mm, Item Number: 814409340

212940 503520 565820 645800 971050

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360

097140 133190 144070

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 380 mm, Item Number: 814409380

053790 155180 762720 790780 813530

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 400 mm, Item Number: 814409400

051130 053810 133200 153200 813940 097150 767720

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420

503570 790820

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 440 mm, Item Number: 814409440

503610 900270

Product: Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460

097160 133230

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 260 mm, Item Number: 814411260

503640

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320

155130 813600

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340

530180 585810

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360

503700 646540 707750 519470

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 380 mm, Item Number: 814411380

053940 813860 886990

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400

053980 053990 646590 768010 530100 646600

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420

155120 245960 472890 813680 813860

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 440 mm, Item Number: 814411440

151870 155110 646620 960600 646630 646640

Product: Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 460 mm, Item Number: 814411460

054000 097060 285050 287410

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260

814090

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280

559130

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 300 mm, Item Number: 814413300

331610

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 320 mm, Item Number: 814413320

245830 331620

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 340 mm, Item Number: 814413340

482730 155980 156040

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 360 mm, Item Number: 814413360

054030 054040 312200 312210

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380

417480 646660

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 400 mm, Item Number: 814413400

054100 646680

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420

155080 156070 156150 482640 762730

Product: Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 460 mm, Item Number: 814413460

155070

Product: Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180

054130 085710 144520 150790 156740 156750 219790 245740 245820 287290 287400 456140 482650 707780 900280 944590 944630 944640 970640 609640 609650

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 260 mm, Item Number: 814509260

813650

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 280 mm, Item Number: 814509280

768020

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300

212980 128150 971560

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 320 mm, Item Number: 814509320

530190 887000 971580

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 340 mm, Item Number: 814509340

503940 646730

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360

813470 646750

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380

628920 646790 773060

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400

646830 900740

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 420 mm, Item Number: 814509420

153010 159190 707830 503950 503960

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 440 mm, Item Number: 814509440

054150 054170 130740 130750 188310 519480 472970 503970

Product: Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 460 mm, Item Number: 814509460

254720 017420 960610

Product: Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180

072620 130760 130770 130780 130790 130800 130810 130820 130840 130850 130860 130900 130920 131030 156770 157000 188340 219800 219810 219820 219910 245570 245690 287090 287120 287130 371170 456160 519490 530110 530120 530130 558980 565870 565880 601390 707920 768050 772730 854270 901300 901330 901350 901360 901370 901380 901400 901410 944660 944720 970790 970810 970820 970830 970840 970850 970860 970870 970880 970890 130930 130940 156970 503980 503990 504000 504010

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 260 mm, Item Number: 814511260

791640 813460

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280

155000 483480 646910 646930 646950 353610

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 300 mm, Item Number: 814511300

558960

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 320 mm, Item Number: 814511320

331650

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340

054180 483490 519590 558900 558910 586640 371200

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360

107830 107850 152910 154990 482740 519610 565900 707960 762780 773410 812310 812330 097190 696380

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380

054200 054210 054220 519620 519630 813210

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400

054240 054250 154980 472860 773390 798600 798610 017490 245530

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 420 mm, Item Number: 814511420

154960 558870 558880 628930 707860 171860 171870

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 440 mm, Item Number: 814511440

213000 558850

Product: Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 460 mm, Item Number: 814511460

157130 558840 710910

Product: Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180

063590 063600 220020 245510 290720 371210 482750 482760 482770 523410 097180 188350 188370 290690 970510 970530 970580

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260

901420

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280

213010 707970 944730

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300

944850

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340

017700

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380

587670 707980 711060

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 400 mm, Item Number: 814513400

152980 482780 530160 798520 798530 798540 773050

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm, Item Number: 814513420

060800 060820 397280 397290 397300 812970 901490 418360

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 440 mm, Item Number: 814513440

154920 711080 017710

Product: Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460

558790 711090 901520

Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm, Item Number: 814515320

154900 818440

Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360

154890 814740

Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400

364250

Product: Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440

154880

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 260 mm, Item Number: 814609260

157170

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 280 mm, Item Number: 814609280

107860 558680 791850 091560

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 320 mm, Item Number: 814609320

055260 154870 721080

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360

287140

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 400 mm, Item Number: 814609400

055360 055510 157290 917700 972060 812750 812920 812930

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 420 mm, Item Number: 814609420

762840

Product: Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 460 mm, Item Number: 814609460

055580 154820 154830 245470

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260

091610 558640 629150

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 280 mm, Item Number: 814611280

711150 711170

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 320 mm, Item Number: 814611320

331940 558590 900100

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 340 mm, Item Number: 814611340

154800 154810 155350 629170 157430 587790 944920

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360

017730 085400 154660 154670 154680 157450 558510 565960 694270 711210 812570 812730 818350 945040 629800

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380

152900 154610 901540 901550 901560 901570 901580 901590 901600 565970 609690

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400

060780 154560 482790 530170 759190 797000 797020 812460 812540 759180

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 420 mm, Item Number: 814611420

154540 155340 712170 791890 712240 812340

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440

558490 759400

Product: Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 460 mm, Item Number: 814611460

171830 712290

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 260 mm, Item Number: 814613260

171820 972190

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280

688510 763000

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 300 mm, Item Number: 814613300

818430 960660

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320

245390 287180

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 340 mm, Item Number: 814613340

331960

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360

816070 091850

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380

712320 145040

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400

055730 060770 154510 558410 712370 543380

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420

154480 482820

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 440 mm, Item Number: 814613440

157490 482830

Product: Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 460 mm, Item Number: 814613460

055760 154460 503740 558390 712400

Product: Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360

154450 791930

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80755
Status: Resolved
Manufacturer: Zimmer Biomet, Inc.
Manufactured In: United States
Units Affected: 129 products (5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total; 5947 total)
Agency Last Updated: October 17, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.