CLASS II ONGOING Device recall · Reported 12 May 2021 · FDA Enforcement Report
Grace Medical recalled by Oto Med
Oto Med is recalling Grace Medical, distributed nationwide in the US. The recall was initiated on 7 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1521-2021
- FDA event ID
- 87577
- Recalling firm
- Oto Med, Lake Havasu City, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Dec 2020
- FDA classified
- 30 Apr 2021
- Reported
- 12 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Device type
- Spinal Implants
Timeline
| 7 Dec 2020 | Recall initiated by company | |
| 30 Apr 2021 | Classified by FDA | +144 days |
| 12 May 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Grace Medical recalled?
Yes. Oto Med recalled Grace Medical on 7 Dec 2020. The recall is Class II and its status is Ongoing. Recall number Z-1521-2021.
Why was it recalled?
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Which lots are affected?
UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Oto Med
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grace Medical recalled by Oto Med | Oto Med | Particulate Matter | Nationwide |
| Device | CLASS II | Grace Medical recalled by Oto Med | Oto Med | Particulate Matter | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |