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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Sustainability Solutions (SSS)

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  Class 2 Device Recall Stryker Sustainability Solutions (SSS) see related information
Date Initiated by Firm July 27, 2018
Create Date March 05, 2019
Recall Status1 Terminated 3 on September 17, 2020
Recall Number Z-0973-2019
Recall Event ID 82063
510(K)Number K012605  
Product Classification Arthroscope - Product Code HRX
Product 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact Marissa Richmond
480-763-5300 Ext. 5034
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
Action On July 26, 2018, Stryker Sustainability Solutions sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter to affected consignees asking them to follow the instructions in the letter. The letter also included a risk evaluation these devices may pose to end users and their patients. According to the Urgent Medical Device Recall Customer Notification Letter there are no harms associated with the use of affected reprocessed arthroscopic shavers. 1) Noncompatible devices are rendered inactive with console and alternative surgical methods are readily available. 2) Incorrect spin speed does not result in any harm to the patient The letter also informed customers to; 1) discontinue use of affected reprocessed arthroscopic shavers; 2) complete the recall effectiveness check form and indicate if any of the affected product remains in their inventory; 3)Return the completed form either via e-mail to SSSPFA@Stryker.com or to their Stryker Sustainability Solutions sales rep, or via fax to 480.763.5345; 4) If no product is in inventory customers are also being told to complete the recall effectiveness check form and send in as described above; 5) finally any adverse events or quality problems experienced with the use of this product should be reported to: The FDAs MedWatch Adverse Event Reporting program either online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home, by regular mail or by fax; Strykers Sustainability Solutions division complaint hotline: +1 888 763 8803 or http://www.stryker.com/productexperience
Quantity in Commerce 14,265 units
Distribution Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. OUS Israel and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = ALLIANCE MEDICAL CORP.
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