FDA Medical Device Recalls (openFDA)
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 number
- Z-1521-2021
- Recalling firm
- Oto Med Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2020-12-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
- Root cause
- 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
- 415 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.
- Lot, serial or model codes
- UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MXP
- Firm FEI
- 2021687
- Firm city
- Lake Havasu City
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28