FDA Device recall Z-2421-2015
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE P…
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE P… by Trilliant Surgical, citing the cutting efficiency of the Countersinks was out of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2421-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-20 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trilliant Surgical |
| Distribution | US |
Product
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Reason
The cutting efficiency of the Countersinks was out of specification.
Identifiers
| code_info | Lot numbers 1362-01 and 1364-01 |
|---|
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-2421-2015%22
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