Z-1519-2021Class II

Grace Medical REF S-2500 * SHEEHY BONE DUST COLLECTOR * Stainless steel filter -

Name: Z-1519-2021 Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter -
Creator: Oto Med Inc
Published: 2020-12-07
License: https://open.fda.gov/license/

Oto Med Inc / initiated 2020-12-07 / Open, Classified / root cause: packaging

FDA source

Oto Med Inc began a recall of Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the... on 2020-12-07. FDA classified it as Class II and gives the reason as "During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1519-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-07
Posted: 2021-04-30
Recalling firm: Oto Med Inc
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.
Product code: MXP Bone Particle Collector
Reason for recall: During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Root cause tag: packaging
FDA 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 [email protected].
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.
Product codes and lots: UDI Code: 00850000126046 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200401

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1519-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30
Z-1520-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30
Z-1521-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30

Product code MXP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)