Oto Med Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Oto Med Inc
Lot Codes / Batch Numbers
UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Products Sold
UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Oto Med Inc is recalling Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usag due to During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026