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U.S. Department of Health and Human Services

Class 2 Device Recall Knee Arthroscopy Pack

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 Class 2 Device Recall Knee Arthroscopy Packsee related information
Date Initiated by FirmJanuary 11, 2017
Date PostedFebruary 28, 2017
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-1320-2017
Recall Event ID 76280
Product Classification Light, surgical, ceiling mounted - Product Code FSY
ProductKnee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860
Code Information Lot number and expiration date  100023, 9/22/2019 100595, 9/1/2019 84529, 5/13/2018 84584, 5/26/2018 84728, 5/25/2018 85250, 7/22/2018 85273, 7/10/2018 85645, 8/1/2018 85845, 8/19/2018 87286, 8/11/2019 87350, 9/21/2018 87967, 9/24/2018 88173, 11/11/2018 88390, 11/21/2018 88627, 12/24/2018 89082, 10/3/2018 89422, 12/16/2018 89511, 11/13/2018 94573, 11/19/2018 94941, 11/20/2018 95452, 5/6/2019 95985, 3/8/2019 97273, 5/22/2019 98169, 6/26/2019 98664, 6/25/2019 98675, 6/23/2019 99375, 6/12/2019
FEI Number 1000125955
Recalling Firm/
Manufacturer		 Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
For Additional Information ContactVicki Davis
321-527-7714
Manufacturer Reason
for Recall		The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.
Quantity in Commerce700 kits
DistributionDistributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
Total Product Life CycleTPLC 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.
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