Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2… — Class II medical device recall Z-1521-2021
Ongoing recall by Oto Med Inc, reported 2021-05-12, distributed nationwide. During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
| Recall number | Z-1521-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oto Med Inc, Lake Havasu City, AZ, United States |
| Recall initiated | 2020-12-07 |
| Classified | 2021-04-30 |
| Reported by FDA | 2021-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BR, CA, CL, CO, HK, IN, TW, ZA |
| Quantity | 415 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00850000126077 |
| Lot numbers | 019120G |
| Model numbers | 4500 |
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.
Reason for recall
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1521-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.