various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty
Class I - DangerousWhat Should You Do?
- Check if you have this product: Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130 712810 712830 712850 712860 Item 11-105911 577890 Item 11-105912 577920 Item 11-105913 577930 Item 11-105933 577950 Item 11-165208 779480 797810 Item 11-165216 905190 Item 11-165220 905230 Item 11-165222 808510 905270 920560 Item 11-165224 905130 Item 11-165226 758530 758550 797970 920600 Item 11-165228 879860 Item 11-165232 716050 732560 732580 920670 Item 11-165236 896290 Item 11-165240 779430 Item 12-105994 272230 Item CP162598 354160 Item EP-105833 371770 Item EP-105882 604860 Item EP-105894 371780 667310 Item EP-105914 371640 443510 443520 667250 667260 Item EP-105916 455050 577290 Item EP-105917 577300 Item EP-105918 577250 Item EP-105923 455070 577320 577340 728050 728080 728150 728180 Item EP-105925 577380 Item EP-105926 577390 Item EP-105933 455080 577360 Item EP-105934 604870 Item EP-105996 577420 Item EP-107926 811990 Item EP-108223 275040 Item EP-108322 371730 Item EP-108323 371740 667290 667300 Item EP-108424 272270 455100 Item EP-108425 455110 Item EP-108524 455120 Item EP-108525 240900 Item EP-176238 602380 Item EP-200144 455130 455150 728200 728220 Item EP-200146 390550 577450 577460 577480 Item EP-200148 511810 511820 511830 511840 511880 728230 728240 Item EP-200150 455180 455190 511890 511900 511910 728250 728270 Item EP-200152 455200 728300 728320 728340 Item EP-200154 455210 Item EP-200156 577490 577500 Item EP-200158 577510 577520 ItemEP-200160 455220 Item XL-105833 542210 542220 542230 542240 Item XL-105834 542250 Item XL-105835 614420 Item XL-105884 604960 Item XL-105885 588450 Item XL-105903 502330 502340 Item XL-105905 588490 Item XL-105914 502370 502380 Item XL-105923 290100 502390 502410 779270 Item XL-105924 309510 502430 502440 779340 Item XL-105925 502450 Item XL-105933 309520 502460 605000 779590 Item XL-105934 290110 502490 Item XL-105994 309530 Item XL-108222 290120 Item XL-108223 605040 Item XL-200144 605050 Item XL-200146 502590 644000 Item XL-200148 290130 502600 502610 Item XL-200150 502620 502630 Item XL-200152 502640 Item XL-200154 290140 Item XL-200158 502650 Item XL-200160 644030 Item XL-222846 290150 Item XL-223248 290160
- 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:
- Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty
Product Codes/Lot Numbers:
Items and lots: Item 11-105900 712480 Item 11-105901 695030 695040 Item 11-105902 309540 605110 605120 605130 712810 712830 712850 712860 Item 11-105911 577890 Item 11-105912 577920 Item 11-105913 577930 Item 11-105933 577950 Item 11-165208 779480 797810 Item 11-165216 905190 Item 11-165220 905230 Item 11-165222 808510 905270 920560 Item 11-165224 905130 Item 11-165226 758530 758550 797970 920600 Item 11-165228 879860 Item 11-165232 716050 732560 732580 920670 Item 11-165236 896290 Item 11-165240 779430 Item 12-105994 272230 Item CP162598 354160 Item EP-105833 371770 Item EP-105882 604860 Item EP-105894 371780 667310 Item EP-105914 371640 443510 443520 667250 667260 Item EP-105916 455050 577290 Item EP-105917 577300 Item EP-105918 577250 Item EP-105923 455070 577320 577340 728050 728080 728150 728180 Item EP-105925 577380 Item EP-105926 577390 Item EP-105933 455080 577360 Item EP-105934 604870 Item EP-105996 577420 Item EP-107926 811990 Item EP-108223 275040 Item EP-108322 371730 Item EP-108323 371740 667290 667300 Item EP-108424 272270 455100 Item EP-108425 455110 Item EP-108524 455120 Item EP-108525 240900 Item EP-176238 602380 Item EP-200144 455130 455150 728200 728220 Item EP-200146 390550 577450 577460 577480 Item EP-200148 511810 511820 511830 511840 511880 728230 728240 Item EP-200150 455180 455190 511890 511900 511910 728250 728270 Item EP-200152 455200 728300 728320 728340 Item EP-200154 455210 Item EP-200156 577490 577500 Item EP-200158 577510 577520 ItemEP-200160 455220 Item XL-105833 542210 542220 542230 542240 Item XL-105834 542250 Item XL-105835 614420 Item XL-105884 604960 Item XL-105885 588450 Item XL-105903 502330 502340 Item XL-105905 588490 Item XL-105914 502370 502380 Item XL-105923 290100 502390 502410 779270 Item XL-105924 309510 502430 502440 779340 Item XL-105925 502450 Item XL-105933 309520 502460 605000 779590 Item XL-105934 290110 502490 Item XL-105994 309530 Item XL-108222 290120 Item XL-108223 605040 Item XL-200144 605050 Item XL-200146 502590 644000 Item XL-200148 290130 502600 502610 Item XL-200150 502620 502630 Item XL-200152 502640 Item XL-200154 290140 Item XL-200158 502650 Item XL-200160 644030 Item XL-222846 290150 Item XL-223248 290160
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1860-2017
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.