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Open, Classified

Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

FDA Recall Z-1521-2021 · Posted None

Recalling FirmOto Med Inc
Recall StatusOpen, Classified
Product CodeMXP
Date Initiated2020-12-07
Product Quantity415 devices

Reason for Recall

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

Firm 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 [email protected].

Root Cause

Package design/selection

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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