XP-XP Tibial Tray - Interlok 83 mm Item # 195759

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number 559070 527660 677630 191210 219890 677620 758460 089950 283100 358850 283080 374620 321750 321770 358830 374580 374590 420310 420320 434060 358860 381760 321690 358840 468200 381770 381780 381780R 321710 434070 420290 468210 023420 011510 864760 093450 093460 885140 855480 975650 828760 061480 331670 103080 131270 159350 116110 223220 116110R 587400 181490 418770 634280 664240 783170 716000 906810 685020 882160 882170 881950 715990 986210 396500 986200 906820 029310 126100 163080 247440 293200 293210 163090 126090 920640 920640R 481960 073030 374570 442040 442050 318630 479060 509960 509930 450480 183670 479050 576240 543440 543450 625770 593670 639750 670660 758590 741610 481970 943600 808440 917680 951040 780300 833290 851020 873620 481950 018270 999420 076780
  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:
The locking bar not fully engaging
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

XP-XP Tibial Tray - Interlok 83 mm Item # 195759

Product Codes/Lot Numbers:

Lot Number 559070 527660 677630 191210 219890 677620 758460 089950 283100 358850 283080 374620 321750 321770 358830 374580 374590 420310 420320 434060 358860 381760 321690 358840 468200 381770 381780 381780R 321710 434070 420290 468210 023420 011510 864760 093450 093460 885140 855480 975650 828760 061480 331670 103080 131270 159350 116110 223220 116110R 587400 181490 418770 634280 664240 783170 716000 906810 685020 882160 882170 881950 715990 986210 396500 986200 906820 029310 126100 163080 247440 293200 293210 163090 126090 920640 920640R 481960 073030 374570 442040 442050 318630 479060 509960 509930 450480 183670 479050 576240 543440 543450 625770 593670 639750 670660 758590 741610 481970 943600 808440 917680 951040 780300 833290 851020 873620 481950 018270 999420 076780

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2518-2019

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.

Nov 17, 2020 Other Medical Devices Nationwide View Details →