XP-CR Tibial Tray - Interlok 73mm Item # 195274
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 553880 590760 663690 553880R 590750 663670 262430 513080 663720 513080R 472990 938180 578980 090230 159280 676320 258090 043920 066220 206850 322110 352860 841550 917740 966760 283230 374810 283240 996010 352850 352850R 429270 851300 383710 041300 585600 076010 469520 578970 599150 600800 600800R 279040 450360 672600 374090 943410 712580 121150 018040 821330 121140 199740 218670 717190 308100 308110 502840 513070 571040 502840R 513070R 571040R
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 73mm Item # 195274
Product Codes/Lot Numbers:
Lot Number 553880 590760 663690 553880R 590750 663670 262430 513080 663720 513080R 472990 938180 578980 090230 159280 676320 258090 043920 066220 206850 322110 352860 841550 917740 966760 283230 374810 283240 996010 352850 352850R 429270 851300 383710 041300 585600 076010 469520 578970 599150 600800 600800R 279040 450360 672600 374090 943410 712580 121150 018040 821330 121140 199740 218670 717190 308100 308110 502840 513070 571040 502840R 513070R 571040R
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2509-2019
Related Recalls
Device has the potential for fracture during use.
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet
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.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.