XP-CR Tibial Tray - Interlok 67mm Item # 195271

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number 486100 262400 291180 584260 663550 562250 666830 660450 841520 917700 966720 966720R 075450 075460 075500 663530 995960 322020 043860 090190 206820 075440 745670 352820 383680 075470 745650 513340 159230 258060 429230 161960 161950 161930 161910 161920 162010 161860 274480 161870 161900 274460 996070 274490 274510 721690 322000 456750 456750R 274470 374780 951150 075510 469490 721670 309710 274500 309680 309690 075490 309700 585540 883560 221140 374030 920540 279010 450330 672510 575980 821280 943360 599120 600770 712550 717160 017970 076400 076410 220040 175290 175290R 289160 676270 676300 228610 351290 395400 395420 445370 395400R
  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-CR Tibial Tray - Interlok 67mm Item # 195271

Product Codes/Lot Numbers:

Lot Number 486100 262400 291180 584260 663550 562250 666830 660450 841520 917700 966720 966720R 075450 075460 075500 663530 995960 322020 043860 090190 206820 075440 745670 352820 383680 075470 745650 513340 159230 258060 429230 161960 161950 161930 161910 161920 162010 161860 274480 161870 161900 274460 996070 274490 274510 721690 322000 456750 456750R 274470 374780 951150 075510 469490 721670 309710 274500 309680 309690 075490 309700 585540 883560 221140 374030 920540 279010 450330 672510 575980 821280 943360 599120 600770 712550 717160 017970 076400 076410 220040 175290 175290R 289160 676270 676300 228610 351290 395400 395420 445370 395400R

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2506-2019

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 →