—#180454

Product

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

FDA product code: KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K080979, K161166
Affected lot / code info: ***Lot Numbers*** 331870, 050670, 628200, 977700, 487840, 680310, 062930, 437310, 736420, 129860, 084270, 262430, 474140, 176350, 520540, 957200, 265730, 713220, 584750, 817700, 021270, 301460, 063240, 188820, 188830, 061870, 061860, 932970, 374990, 375000, 602360, 680450, 792230, 655550, 092840, 205930, 771040, 774460, 774450, 016170, 997520, 188490, 400250, 147560, 291850, 548320, 396960, 396950, 632020, 234510, 809670, 809680, 164180, 070740, 916120, 070650, 070710, 070720, 164170, 224520, 224530, 295880, 295890, 295900, 388410, 388430, 388440, 401930, 552620, 552630, 552640, 552650, 617990, 070690, 224510, 315420, 401920, 431570, 618010, 070730, 388420, 388460, 548610, 034780, 275370, 737120, 808040, 875330, 144810, 042920, 070730R, 639790, 639860, 639880, 639930, 262130, 639850, 639920, 639940, 639950, 313660, 313670, 326880, 374130, 717760, 717770, 717780, 717790, 717800, 717810, 717820, 717830, 717840, 812850, 813890, 813910, 809680R, 037600, 063860, 063870, 210830, 388460R, 772750, 806560, 806640, 806790, 029310, 807400, 807540, 894170, 117910, 250580, 331000, 488060, 554700, 605700, 673830, 689840, 689850, 834890, 813910R, 834900, 834920, 834880, 834910, 865950, 865940, 946990,***UDI Numbers*** (01)00880304521148(17)160128(10)331870, (01)00880304521148(17)160628(10)050670, (01)00880304521148(17)160928(10)628200, (01)00880304521148(17)161128(10)977700, (01)00880304521148(17)170428(10)487840, (01)00880304521148(17)170528(10)680310, (01)00880304521148(17)170628(10)062930, (01)00880304521148(17)171128(10)437310, (01)00880304521148(17)171206(10)736420, (01)00880304521148(17)171228(10)129860, (01)00880304521148(17)171228(10)084270, (01)00880304521148(17)180116(10)262430, (01)00880304521148(17)180203(10)474140, (01)00880304521148(17)180416(10)176350, (01)00880304521148(17)180619(10)520540, (01)00880304521148(17)180730(10)957200, (01)00880304521148(17)180826(10)265730, (01)00880304521148(17)181009(10)713220, 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(01)00880304521148(17)230118(10)552620, (01)00880304521148(17)230124(10)552630, (01)00880304521148(17)230124(10)552640, (01)00880304521148(17)230119(10)552650, (01)00880304521148(17)230123(10)617990, (01)00880304521148(17)230125(10)070690, (01)00880304521148(17)230124(10)224510, (01)00880304521148(17)230125(10)315420, (01)00880304521148(17)230128(10)401920, (01)00880304521148(17)230125(10)431570, (01)00880304521148(17)230125(10)618010, (01)00880304521148(17)230205(10)070730, (01)00880304521148(17)230312(10)388420, (01)00880304521148(17)230309(10)388460, (01)00880304521148(17)230408(10)548610, (01)00880304521148(17)230412(10)034780, (01)00880304521148(17)230416(10)275370, (01)00880304521148(17)230417(10)737120, (01)00880304521148(17)230412(10)808040, (01)00880304521148(17)230416(10)875330, (01)00880304521148(17)230420(10)144810, (01)00880304521148(17)230510(10)042920, (01)00880304521148(17)230205(10)070730R, (01)00880304521148(17)240513(10)639790, (01)00880304521148(17)240521(10)639860, (01)00880304521148(17)240520(10)639880, (01)00880304521148(17)240520(10)639930, (01)00880304521148(17)240525(10)262130, (01)00880304521148(17)240527(10)639850, (01)00880304521148(17)240521(10)639920, (01)00880304521148(17)240527(10)639940, (01)00880304521148(17)240527(10)639950, (01)00880304521148(17)240529(10)313660, (01)00880304521148(17)240529(10)313670, (01)00880304521148(17)240612(10)326880, (01)00880304521148(17)240716(10)374130, (01)00880304521148(17)240612(10)717760, (01)00880304521148(17)240613(10)717770, (01)00880304521148(17)240614(10)717780, (01)00880304521148(17)240611(10)717790, (01)00880304521148(17)240612(10)717800, (01)00880304521148(17)240616(10)717810, (01)00880304521148(17)240613(10)717820, (01)00880304521148(17)240613(10)717830, (01)00880304521148(17)240613(10)717840, (01)00880304521148(17)240612(10)812850, (01)00880304521148(17)240613(10)813890, (01)00880304521148(17)240613(10)813910, (01)00880304521148(17)221218(10)809680R, (01)00880304521148(17)240828(10)037600, (01)00880304521148(17)240830(10)063860, (01)00880304521148(17)240830(10)063870, (01)00880304521148(17)240830(10)210830, (01)00880304521148(17)230309(10)388460R, (01)00880304521148(17)241009(10)772750, (01)00880304521148(17)241009(10)806560, (01)00880304521148(17)241002(10)806640, (01)00880304521148(17)241002(10)806790, (01)00880304521148(17)241011(10)029310, (01)00880304521148(17)241011(10)807400, (01)00880304521148(17)241009(10)807540, (01)00880304521148(17)241009(10)894170, (01)00880304521148(17)241024(10)117910, (01)00880304521148(17)241024(10)250580, (01)00880304521148(17)241024(10)331000, (01)00880304521148(17)241106(10)488060, (01)00880304521148(17)241119(10)554700, (01)00880304521148(17)241119(10)605700, (01)00880304521148(17)241209(10)673830, (01)00880304521148(17)241204(10)689840, (01)00880304521148(17)241204(10)689850, (01)00880304521148(17)241218(10)834890, (01)00880304521148(17)240613(10)813910R, (01)00880304521148(17)241218(10)834900, (01)00880304521148(17)241219(10)834920, (01)00880304521148(17)250104(10)834880, (01)00880304521148(17)250104(10)834910, (01)00880304521148(17)250102(10)865950, (01)00880304521148(17)250110(10)865940, (01)00880304521148(17)250123(10)946990, (01)00880304521148(17)250123(10)973880 973880.

Why it was recalled

Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Root cause (FDA determination)

Process control

Action the firm took

On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

Timeline

Recall initiated: 2020-02-26
Posted by FDA: 2020-04-03
Terminated: 2021-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.