Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000 375-951-000, 375-555-000 375-951-012, 375-562-000 375-951-100, 375-564-000 375-951-112, 375-565-000 375-951-200 and 375-747-000 375-952-000. Lots from affected catalog numbers: 4601435 7687551 7954336 8069955 8143951 8213505 8290940 4866597 7692818 7957638 8078776 8143979 8216233 8296920 5275122 7695149 7962443 8078965 8144105 8220563 8297887 5810401 7696653 7964118 8079076 8144770 8220748 8297970 6165680 7702505 7964966 8082376 8146583 8223629 8298035 6552450 7725942 7965089 8082638 8148337 8223910 8298128 6563177 7743624 7969196 8082746 8150492 8224388 8298625 6634381 7755555 7978089 8095770 8150617 8224621 8305181 6694100 7766506 7978931 8096123 8150664 8228215 8305467 6705350 7767267 7981959 8096255 8152993 8228340 8305524 6712065 7768175 7986332 8096613 8153141 8228408 8305595 6761681 7782229 7991417 8099709 8153248 8231445 8308196 6819315 7821595 7997091 8100287 8153419 8231599 8308261 7066139 7829681 8004687 8100406 8153658 8231736 8310523 7076865 7831750 8007843 8104913 8154010 8231864 8320330 7119659 7838095 8016985 8104966 8159807 8232000 8320617 7129915 7839027 8022071 8105004 8159895 8235618 8323092 7184490 7840722 8028142 8105058 8161407 8244348 8323194 7196683 7842014 8028208 8105299 8163785 8244353 8323457 7252265 7842476 8028220 8105378 8163860 8244492 8323899 7370055 7842578 8028556 8113641 8163873 8244519 8330243 7383670 7851733 8028637 8113734 8166754 8247857 8339095 7403808 7852107 8036566 8113809 8167287 8251682 8339146 7413359 7852182 8036815 8113845 8170405 8251719 8352883 7428476 7865156 8040157 8117025 8170763 8251844 8359800 7455721 7868429 8040323 8117115 8172102 8251994 8367003 7505081 7869132 8045052 8121520 8177364 8252345 8367185 7505505 7874618 8045121 8121667 8181204 8257718 8377347 7535206 7879255 8045270 8121786 8181289 8265008 8388727 7544440 7879286 8048728 8125248 8181408 8265217 8397197 7567055 7903097 8049139 8125474 8181431 8267426 8400191 7597084 7903772 8049230 8129960 8188037 8267517 8418674 7615431 7911516 8053354 8130103 8188419 8272680 8423234 7624503 7924275 8053383 8130220 8192179 8273138 8423268 7624733 7929803 8056987 8130853 8196392 8273172 8424154 7655856 7933324 8064615 8131232 8196545 8273275 8424316 7674248 7933542 8064847 8131395 8196681 8276053 8424407 7674643 7938522 8065027 8131601 8196702 8287528 8440175 7685438 7941629 8069917 8143807 8213465 8290290 8462684
- 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:
- Stryker Sustainability Solutions
- Reason for Recall:
- Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Product Codes/Lot Numbers:
Catalog Numbers: 375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000 375-951-000, 375-555-000 375-951-012, 375-562-000 375-951-100, 375-564-000 375-951-112, 375-565-000 375-951-200 and 375-747-000 375-952-000. Lots from affected catalog numbers: 4601435 7687551 7954336 8069955 8143951 8213505 8290940 4866597 7692818 7957638 8078776 8143979 8216233 8296920 5275122 7695149 7962443 8078965 8144105 8220563 8297887 5810401 7696653 7964118 8079076 8144770 8220748 8297970 6165680 7702505 7964966 8082376 8146583 8223629 8298035 6552450 7725942 7965089 8082638 8148337 8223910 8298128 6563177 7743624 7969196 8082746 8150492 8224388 8298625 6634381 7755555 7978089 8095770 8150617 8224621 8305181 6694100 7766506 7978931 8096123 8150664 8228215 8305467 6705350 7767267 7981959 8096255 8152993 8228340 8305524 6712065 7768175 7986332 8096613 8153141 8228408 8305595 6761681 7782229 7991417 8099709 8153248 8231445 8308196 6819315 7821595 7997091 8100287 8153419 8231599 8308261 7066139 7829681 8004687 8100406 8153658 8231736 8310523 7076865 7831750 8007843 8104913 8154010 8231864 8320330 7119659 7838095 8016985 8104966 8159807 8232000 8320617 7129915 7839027 8022071 8105004 8159895 8235618 8323092 7184490 7840722 8028142 8105058 8161407 8244348 8323194 7196683 7842014 8028208 8105299 8163785 8244353 8323457 7252265 7842476 8028220 8105378 8163860 8244492 8323899 7370055 7842578 8028556 8113641 8163873 8244519 8330243 7383670 7851733 8028637 8113734 8166754 8247857 8339095 7403808 7852107 8036566 8113809 8167287 8251682 8339146 7413359 7852182 8036815 8113845 8170405 8251719 8352883 7428476 7865156 8040157 8117025 8170763 8251844 8359800 7455721 7868429 8040323 8117115 8172102 8251994 8367003 7505081 7869132 8045052 8121520 8177364 8252345 8367185 7505505 7874618 8045121 8121667 8181204 8257718 8377347 7535206 7879255 8045270 8121786 8181289 8265008 8388727 7544440 7879286 8048728 8125248 8181408 8265217 8397197 7567055 7903097 8049139 8125474 8181431 8267426 8400191 7597084 7903772 8049230 8129960 8188037 8267517 8418674 7615431 7911516 8053354 8130103 8188419 8272680 8423234 7624503 7924275 8053383 8130220 8192179 8273138 8423268 7624733 7929803 8056987 8130853 8196392 8273172 8424154 7655856 7933324 8064615 8131232 8196545 8273275 8424316 7674248 7933542 8064847 8131395 8196681 8276053 8424407 7674643 7938522 8065027 8131601 8196702 8287528 8440175 7685438 7941629 8069917 8143807 8213465 8290290 8462684
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0973-2019
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