Class 2 Device Recall Aligned Medical

• Date Initiated by Firm: November 01, 2022
• Date Posted: January 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0881-2023
• Recall Event ID: 91157
• Product Classification: Kit, surgical instrument, disposable - Product Code KDD
• Product: Various Custom Surgical Instrument Disposable Kits:; Part Numbers / Product Description; 26000004M Custom Lasik Kit; AMS10411A Nasal Endoscopy Pack; AMS10710A Ultrasound Tray w/PDI; AMS11941 Total Knee Pack; AMS12138B Eye Pack; AMS12278B Body Pack; AMS12341A Hassan Pack; AMS12341B Hassan Pack; AMS12343A Meldrum Pack; AMS12359B Neuro Pack; AMS12520 Total Hip Pack; AMS12608 Extremity Pack; AMS12610 Shoulder Pack; AMS12636 Dr. Thompson Pack; AMS12689A Custom Pack; AMS12753 Breast Pack; AMS12754 Abdominoplasty Pack; AMS12769 Minor Pack; AMS12926 Shoulder Pack; AMS12927 Retina Pack; AMS13428 Hand Pack; AMS2120D Plastics Tray; AMS2890(B Basic Biopsy Tray; AMS3824(A Myelogram Tray - RX; AMS4022F Lami Pack; AMS4371C Lasik Eye Pack; AMS4372 Plastic Eye Pack; AMS4599(C Spine Pack; AMS4670B Upper Extremity Pack; AMS4766C Shoulder Arthroscopy Pack; AMS4952A Vitrectomy Pack - RX; AMS5697A EVLT Pack; AMS5819B Ortho Major Pack; AMS5887A CARS Pack; AMS6112A Minor Extremity Pack; AMS6112B Minor Extremity Pack; AMS6160C Hip Pack; AMS6277A Procurement Bundle - Pack A/B/C; AMS6728A Breast Pack; AMS7463B Retrieval Pack; AMS7971 TVOR Pack; AMS8094 Plastics Eye Pack; AMS8664B Spinal Pack; AMS8989 Hysteroscopy Pack; AMS9118 Retrieval Pack; AMS9197 Arthroscopy Pack; AMS9435 Foot Pack; AMS9487A Toy Hip Pack; AMS9487B Total Hip Pack; CMP1018G Cataract Kit - Dr. Wright; PSS1838B Medical Imaging Kit; VPP1020A Custom Dental Pack; VPP1023B OR Implant Bundle Pack; WAL1207C Minor Pack
• Code Information: Part Numbers / Product Description / UDI Code: 26000004M Custom Lasik Kit B09826000004M0 Lot Numbers 172743 175939 178701 AMS10411A Nasal Endoscopy Pack B098AMS10411A0 Lot Numbers 167289 171449 176800 AMS10710A Ultrasound Tray w/PDI B098AMS10710A0 Lot Numbers 165400 170502 172266 174545 178063 AMS11941 Total Knee Pack B098AMS119410 Lot Numbers 167985 172632 AMS12138B Eye Pack B098AMS12138B0 Lot Number 173532 AMS12278B Body Pack B098AMS12278B0 Lot Numbers 169016 171534 173220 174960 176107 178175 AMS12341A Hassan Pack B098AMS12341A0 Lot Number 167836 AMS12341B Hassan Pack B098AMS12341B0 Lot Numbers 170376 176035 178108 AMS12343A Meldrum Pack B098AMS12343A0 Lot Numbers 169907 173805 178357 AMS12359B Neuro Pack B098AMS12359B0 Lot Numbers 169315 174926 177785 AMS12520 Total Hip Pack B098AMS125200 Lot Number 172089 AMS12608 Extremity Pack B098AMS126080 Lot Numbers 167069 167271 171686 172416 173221 175365 AMS12610 Shoulder Pack B098AMS126100 Lot Numbers 165469 176734 179262 AMS12636 Dr. Thompson Pack B098AMS126360 Lot Numbers 169693 169902 170466 173025 174576 176208 177411 180470 AMS12689A Custom Pack B098AMS12689A0 Lot Numbers 169549 171027 172750 173642 175088 176507 177771 179109 180349 AMS12753 Breast Pack B098AMS127530 Lot Numbers 168384 171578 176335 AMS12754 Abdominoplasty Pack B098AMS127540 Lot Numbers 168546 171086 AMS12769 Minor Pack B098AMS127690 Lot Numbers 169398 170647 173968 176964 AMS12926 Shoulder Pack B098AMS129260 Lot Numbers 172790 176337 AMS12927 Retina Pack B098AMS129270 Lot Numbers 172376 177356 177598 180851 181069 AMS13428 Hand Pack B098AMS134280 Lot Number 173569 AMS2120D Plastics Tray B098AMS2120D0 Lot Numbers 174742 176986 AMS2890(B Basic Biopsy Tray B098AMS2890B0 Lot Numbers 174253 176930 182598 AMS3824(A Myelogram Tray - RX B098AMS3824A0 Lot Number 177781 AMS4022F Lami Pack B098AMS4022F0 Lot Numbers 168799 168800 168801 169653 171413 171414 172773 173794 174413 177139 177377 177705 177847 177849 178356 178358 179492 179493 180260 AMS4371C Lasik Eye Pack B098AMS4371C0 Lot Number 170046 AMS4372 Plastic Eye Pack B098AMS43720 Lot Numbers 176026 177332 AMS4599(C Spine Pack B098AMS4599C0 Lot Numbers 171036 175421 AMS4670B Upper Extremity Pack B098AMS4670B0 Lot Numbers 167606 168422 169687 170683 171243 173309 174050 176846 178154 178842 AMS4766C Shoulder Arthroscopy Pack B098AMS4766C0 Lot Numbers 168066 172365 177179 AMS4952A Vitrectomy Pack - RX B098AMS4952A0 Lot Number 169163 AMS5697A EVLT Pack B098AMS5697A0 Lot Numbers 171342 173848 175135 176504 AMS5819B Ortho Major Pack B098AMS5819B0 Lot Numbers 168686 171146 173713 AMS5887A CARS Pack B098AMS5887A0 Lot Numbers 169593 171040 171147 172229 173448 174473 175005 175424 177023 178038 178420 179311 AMS6112A Minor Extremity Pack B098AMS6112A0 Lot Number 172500 AMS6112B Minor Extremity Pack B098AMS6112B0 Lot Number 171559 AMS6160C Hip Pack B098AMS6160C0 Lot Numbers 161888 173087 174177 177151 179592 179958 AMS6277A Procurement Bundle - Pack A/B/C B098AMS6277A0 Lot Numbers 172168 175828 176688 177169 178508 179705 180063 AMS6728A Breast Pack B098AMS6728A0 Lot Numbers 164967 180654 AMS7463B Retrieval Pack B098AMS7463B0 Lot Numbers 168899 169309 170342 171177 171639 172537 174848 175470 AMS7971 TVOR Pack B098AMS79710 Lot Numbers 166641 167921 171195 172400 174680 176100 177940 181505 AMS8094 Plastics Eye Pack B098AMS80940 Lot Numbers 163893 174604 AMS8664B Spinal Pack B098AMS8664B0 Lot Numbers 167532 170219 176124 177880 178872 AMS8989 Hysteroscopy Pack B098AMS89890 Lot Numbers 174335 178486 AMS9118 Retrieval Pack B098AMS91180 Lot Numbers 166923 167457 171149 171732 172838 175210 176358 177149 178422 180157 AMS9197 Arthroscopy Pack B098AMS91970 Lot Numbers 167533 172585 175376 AMS9435 Foot Pack B098AMS94350 Lot Numbers 169981 171340 172021 176479 AMS9487A Toy Hip Pack B098AMS9487A0 Lot Number 170102 AMS9487B Total Hip Pack B098AMS9487B0 Lot Numbers 168578 170106 173336 173337 177471 177472 178074 178966 179594 CMP1018G Cataract Kit - Dr. Wright B098CMP1018G0 Lot Numbers 169450 170960 PSS1838B Medical Imaging Kit B098PSS1838B0B Lot Numbers 169452 169680 173823 175798 175799 176797 177249 178693 179849 VPP1020A Custom Dental Pack B098VPP1020A0 Lot Number 171822 VPP1023B OR Implant Bundle Pack B098VPP1023B0 Lot Numbers 167562 171238 173828 WAL1207C Minor Pack B098WAL1207C0 Lot Numbers 169769 170157 170629 172288 174937 176517 177772
• Recalling Firm/ Manufacturer: Windstone Medical Packaging, Inc.; 1602 4th Ave N; Billings MT 59101-1521
• For Additional Information Contact: Jeff Jensen; 406-259-6387
• Manufacturer Reason for Recall: Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
• FDA Determined Cause: Component change control
• Action: On 11/01/2022, firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter was emailed to customers informing them that Align Medical Solutions Convenience Kits were being recalled due to kits containing 3M Steri-Drape Surgical Drapes that have an adhesive component that is difficult to remove without damaging the drape and may render the product unusable. Customers are instructed to: 1. Immediately check their inventory and place affected products under quarantine. 2. Due to the manufacturing process, any finished sterilized packs remaining in inventory, or at their facility will require over labeling for all products affected by this recall. Packs will be labeled with a sticker attached to each pack that reads: RECALL NOTICE - 3M announced the recall of 3M Steri-Drape Surgical Drape(s) contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any 3M Steri-Drape Surgical Drape(s) should be identified and set aside. 2. The recalled 3M Steri-Drape Surgical Drape(s) should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. For questions or concerns contact - fieldcorrectiveaction@alignedmedicalsolutions.com or vdavis@alignedmedicalsolutions.com
• Quantity in Commerce: 9,489 kits
• Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.