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U.S. Department of Health and Human Services

Class 2 Device Recall Grace Medical Bone Collecting Device

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  Class 2 Device Recall Grace Medical Bone Collecting Device see related information
Date Initiated by Firm December 07, 2020
Create Date April 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-1519-2021
Recall Event ID 87577
Product Classification Bone particle collector - Product Code MXP
Product Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
Code Information UDI Code: 00850000126046 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401
Recalling Firm/
Manufacturer		 Oto Med Inc
1090 Empire Dr
Lake Havasu City AZ 86404-2429
For Additional Information Contact Dorothy Gammage
866-472-2363
Manufacturer Reason
for Recall		 During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
FDA Determined
Cause 2		 Package design/selection
Action On 12/07/2020, the firm sent an "URGENT: PRODUCT RECALL NOTICE" Letter via FedEx Overnight (U.S.) and email (O.U.S.) to customer informing them that there is a potential for a hole to develop in the packaging during handling/shipment. Customers are instructed to: 1) Check their inventory for any holes or damage to the pouches, and disposition as specified below: -My inventory has been checked and included none of the affected products. -My inventory has been checked and has no damaged pouches; The product is not being returned. -My inventory has been checked and the product listed is being returned. If returning products, please obtain a Returned Authorization (RA) number. The RA number may be obtained from Customer Service (866-472-2363). In addition, the Response Form must be completed and returned to Grace Medical Group at RECALL COORDINATOR, OTO-MED, INC. c/o GRACE MEDICAL GROUP, INC., 8500 Wolf Lake Drive, Suite 110, Memphis, TN 38133, or by fax to 901-386-0950 or email at info@gracemedical.com.
Quantity in Commerce 13,335 devices
Distribution Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.
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.
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