FDA Device recall Z-1521-2021
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti…
- FDA Device
- Class II
- ongoing
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a sucti… by Oto Med, citing during internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1521-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-07 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Oto Med |
| Distribution | US |
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
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Identifiers
| code_info | UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1521-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.