THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lots 397440 875130 018810 018850 018860 018880 018900 030090 030100 030140 030150 030180 049860 049870 049900 096520 108200 108290 129340 129420 129440 129460 129500 129520 129550 129570 129580 129590 129600 129620 142280 142290 142310 348480 397350 397370 397400 397430 407250 407260 407270 434970 434980 527970 527990 552890 553000 606240 606260 606300 613290 613300 613310 613320 613330 613340 613350 613360 613380 613390 651570 784830 784840 788980 801670 801720 801780 801820 801840 801860 801870 801990 802020 802030 802050 807500 807520 807530 807540 807550 807560 807580 807590 807660 807680 807720 829230 829250 829270 829290 829300 829310 829320 829350 829370 833790 833810 833830 833880 833930 833950 875050 875060 875100 875110 875120 875150 875160 878040 878070 878210 878220 878240 878320 878340 879530 879540 879550 879560 879590 879600 879610 879640 879660 879680 879720 879740 879750 879780 958600 958610 964340 971780 971790 971810 971860 971910 971930 971940 971960 971980 972010 972050 979520 979590 979640 979810 980040
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zimmer Biomet, Inc.
Reason for Recall:
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.

Product Codes/Lot Numbers:

Lots 397440 875130 018810 018850 018860 018880 018900 030090 030100 030140 030150 030180 049860 049870 049900 096520 108200 108290 129340 129420 129440 129460 129500 129520 129550 129570 129580 129590 129600 129620 142280 142290 142310 348480 397350 397370 397400 397430 407250 407260 407270 434970 434980 527970 527990 552890 553000 606240 606260 606300 613290 613300 613310 613320 613330 613340 613350 613360 613380 613390 651570 784830 784840 788980 801670 801720 801780 801820 801840 801860 801870 801990 802020 802030 802050 807500 807520 807530 807540 807550 807560 807580 807590 807660 807680 807720 829230 829250 829270 829290 829300 829310 829320 829350 829370 833790 833810 833830 833880 833930 833950 875050 875060 875100 875110 875120 875150 875160 878040 878070 878210 878220 878240 878320 878340 879530 879540 879550 879560 879590 879600 879610 879640 879660 879680 879720 879740 879750 879780 958600 958610 964340 971780 971790 971810 971860 971910 971930 971940 971960 971980 972010 972050 979520 979590 979640 979810 980040

Distribution:

Distributed in: AL, CA, FL, IA, IL, MD, MI, MN, MO, MS, NC, NE, NJ, NY, PA, TX, UT, VA, WA, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1347-2020

Related Recalls

Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.

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