FDA Device recall Z-1377-2013
***REF S-3D*** 3mm Diamond Ball
- FDA Device
- Class II
- terminated
- Published 2013-06-05
On 2013-06-05 the FDA classified a Class II recall of ***REF S-3D*** 3mm Diamond Ball by The Anspach Effort, citing due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1377-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-03-04 |
| Published | 2013-06-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Reason
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Identifiers
| code_info | Lots numbers: D433040800, D403040236, D383039472. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1377-2013%22
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